DIA Global Regulatory Activity Digest - Drug Information Association

DIA 

Global Regulatory Activity 

Digest 

In our effort to provide you with regulatory updates from around the world, DIA has licensed this content 

from Liquent, parent of the IDRAC regulatory database. 

*** NEW TEXTS THIS WEEK *** 

(From Monday, 12-Sep-2005 to Friday, 16-Sep-2005) 

These documents are available in the IDRAC database as of Tuesday, 20-Sep-2005. 

ARGENTINA 

___________________________________________________________________________ 

ARGENTINA - Disposition 4980/05: Guidelines for the Advertising and Promotion Direct to 

the Public of Free Sale Medicinal Products, Nutritional Products, Cosmetics, Product for 

Personal Hygene, Products for Dental Surgery, In-vitro Diagnostic Reagents, Dietary 

Supplements and Medical Devices, 05-Sep-2005 

This disposition cancels disposition 3186/99 (27694). Annexes III, IV, V and VI are out of the scope of 

IDRAC and have not been included. 

This disposition approves the new guidelines for the advertising and promotion of free-sale medicinal 

products (Annex I), free-sale phytotherapeutical products (Annex II), medical devices (Annex VII) and 

diagnostic reagents (Annex VIII). 

A glossary is available in Annex IX. 

AUSTRALIA 

___________________________________________________________________________ 

AUSTRALIA - ARGCM Amendment Schedule: Version 3.1, Sep-2005 

This Amendment Schedule lists all amendments brought to the different parts of the Australian 

Regulatory Guidelines for Complementary Medicines (ARGCM) from 30-Sep-2004 to 06-Sep-2005: Part I 

(46434), Part II (46481), Part III (43786), Part IV (46196) and Part V (46332). 

AUSTRALIA - Australian Drug Evaluation Committee: Gazettal Notice - Recommendations 

from the 241st Meeting Held on 4&5-Aug-2005, 07-Sep-2005 

This document contains a list of medicines recommended to be approved for registration, subject to the 

resolution of all outstanding matters to the satisfaction of the Australian Drug Evaluation Committee and 

the TGA. These recommendations for approval may be subject to specific conditions. 

AUSTRALIA - Classifying Your In Vitro Diagnostic Device (IVD) and Including It on the 

Australian Register for Therapeutic Goods, Aug-2005 

This presentation has been prepared by the Medical Devices Assessment Section, Office of Devices, Blood 

& Tissues. It explains the system of classification of in vitro diagnostic devices (IVD) into four different 

classes according to the level of public health risk. 

AUSTRALIA - Presentation on the Medical Devices Program for 2005, Aug-2005 

The Medical Devices Program presentation was presented at the Annual Medical Industry Association of

Australia (MIAA) Conference held on 4 August 2005. 

The Medical Devices Program presentation contains a report on activities and assessments of Medical 

Devices, highlighting medical device issues over the past two years and future initiatives, including 

transitional timeframes to be met for Medical Devices in the 2007 transition period. 

AUSTRALIA - Proposed Regulatory Framework for In Vitro Diagnostic Devices (IVDs): 

Conformity Assessment Procedures, Aug-2005 

This presentation has been prepared by the Medical Devices Assessment Section, Office of Devices, Blood 

& Tissues. It is aimed at in vitro diagnostic devices (IVD) sponsors and manufacturers. It was designed to 

update the industry on the proposed regulatory framework for IVDs. 

BRAZIL 

___________________________________________________________________________ 

BRAZIL - Communication ANVISA: Authorization of Marketing and Use of BEXTRA® IM/IV 

(Parecoxib), 13-Sep-2005 

ANVISA announces the cancellation of the prohibition of marketing of BEXTRA© IM/IV (Parecoxib) by 

Pfizer. 

The marketing of BEXTRA© (Valdecoxib) remains prohibited. 

CANADA 

___________________________________________________________________________ 

CANADA - Dear Doctor Letter: Important Safety Information on FORADIL (Formoterol 

Fumarate) AEROLIZER Dry Powder Capsules For Inhalation Safety Update, 07-Sep-2005 

Novartis Pharmaceuticals Canada Inc. ("Novartis") informs of the outcome of the recent U.S. Food and 

Drug Administration's Pulmonary-Allergy Drugs Advisory Committee (PADAC) meeting held on 13-Jul- 

2005 (51391), to discuss the implications of recently available data related to the safety of long acting ß2 

agonist bronchodilators, which includes Novartis' FORADIL (formoterol fumarate) and GlaxoSmithKline's 

SEREVENT (salmeterol) and ADVAIR (salmeterol & fluticasone propionate). 

CANADA - Dear Doctor Letter: Important Safety Information on Metallic Airway Stents, 08- 

Sep-2005 

This letters informs hospitals about complications associated with the use and removal of metallic airway 

stents in patients with benign airway obstruction. Reported complications during stent therapy include 

recurrent obstructions due to granulation tissue formation (requiring repeated interventions), stenosis at 

the ends of the stent, stent fracture, infection, stent migration and mucous obstruction. 

CANADA - Dear Doctor Letter: Important Safety Information on SEREVENT, 07-Sep-2005 

GlaxoSmithKline Inc. (GSK) informs that the product monographs (PM) of SEREVENT/SEREVENT 

DISKHALER/SEREVENT DISKUS and ADVAIR/ADVAIR DISKUS have been updated to include the results 

of the United States Salmeterol Multi-Center Asthma Research Trial (SMART). The preliminary results 

were previously communicated in August 2003 via a "Dear Health Care Professional Letter" (40497). 

CANADA - Dear Doctor Letter: Updated Safety Information Regarding the US FDA 

Pulmonary-Allergy Drugs Advisory Committee (PADAC) Meeting to Review the Safety of the 

Long-Acting Beta Agonists, 07-Sep-2005 

AstraZeneca Canada Inc. provides an update on the outcomes of the US FDA Pulmonary-Allergy Drugs 

Advisory Committee (PADAC) meeting held on 13-Jul-2005 (51391) to review the safety of the long-

acting beta agonists salmeterol and formoterol. 

CANADA - Draft Guidance for Industry: Impurities in Existing Drug Substances and Products, 

06-Sep-2005 

The purpose of this Draft Guidance for Industry is to provide guidance on the identification, qualification, 

and control of impurities for existing drug substances and associated drug products. 

An "existing drug" is one that does not contain a new medicinal ingredient (also known as a new active 

substance), but requires the filing of a New Drug Submission (NDS), an Abbreviated New Drug 

Submission (ANDS) or a Supplement (e.g., generic products). This would include, for example, 

submissions for new dosage forms, new strengths, and other changes to approved products. 

CANADA - Form: NHPD Quality Assurance Report Form 

The Quality Assurance Report (QAR) form is composed of two parts to fill-in: general information and 

detailed quality assurance report. 

Please also refer to the Instructions for Completing a Quality Assurance Report Form (52720). 

A Supplementary Quality Assurance Report Form is also available (42863). 

CANADA - Health Canada Advisory: Sales of Anti-Psychotic Drug Thioridazine to be Stopped, 

08-Sep-2005 

Health Canada advises that manufacturer sales of thioridazine, an anti-psychotic medication used to treat 

schizophrenia, stops by 30-Sep-2005. Health Canada has taken this action because manufacturers have 

failed to provide convincing safety information, requested by the Department, that demonstrates that the 

drug is safe to use. Questions of safety arose from ongoing concerns about use of the medication and 

rare occurrences of heart rhythm changes that could be life-threatening. 

CANADA - Issues in Emerging Health Technologies: Abatacept as Add-On Therapy for 

Rheumatoid Arthritis, Sep-2005 

Abatacept is a co-stimulation blocker that inhibits T-cell activation and interrupts the process leading to 

inflammation in rheumatoid arthritis. 

Patients with severe arthritis who took abatacept with at least one other disease-modifying antirheumatic 

drug in six and 12-month clinical trials demonstrated statistically significant improvement in tender, 

swollen joints and other clinical measures compared with placebo. 

Mild to moderate adverse events included headache, nasopharyngitis, hypertension and back pain. The 

adverse events were similar to those seen in placebo groups. 

Abatacept should not be used in combination with other biologic agents because of reported increased 

rates of serious adverse events, including serious infections; 

With its difference mechanism of action, abatacept may be an alternative add-on therapy for patients 

with an inadequate response to other arthritis therapies. 

CANADA - Method of Medical Treatment Claims in International Applications 

Rule 39.1 of the Patent Cooperation Treaty (PCT) lists subjects for which an International Searching 

Authority (ISA) shall not be required to conduct a search of an international application. It includes 

"methods of treatment of the human or animal body by surgery or therapy". CIPO has taken the position 

that an international search will be conducted on all subject matter which would normally be searched 

and examined in a domestically filed patent application.

CANADA - Newsletter: TPD News, Quarterly Publication of the Therapeutic Products 

Directorate, Fall 2005 

The issues presented in the "TPD News" of Fall 2005 are: 

- Our Growing Relationship with China 

- Message From the Director General 

- Workload Management Forum 

- All-Staff and Volleyball 

- Be Informed, Stay Informed, Inform Others 

- A Day in the Life Of... 

- Moving with Ease 

- Customized Training Programs for Managers 

CANADA - Report of the Adderall XR New Drug Committee, Aug-2005 

At the request of Health Canada (HC) and Shire BioChem Inc (Shire), the "ADDERALL XR New Drug 

Committee" (NDC) was formed to provide recommendations to the Minister of Health relating to the 

decision to suspend the Notice of Compliance (NOC) for ADDERALL XR, a drug formulation of long acting 

amphetamine salts used in the management of Attention Deficit Hyperactivity Disorders (ADHD). 

In light of the NDC findings that there is insufficient evidence to support the belief that there is an 

increased risk of sudden/cardiac death with ADDERALL XR compared to alternate active treatments, but 

also recognizing that such an increase is biologically plausible and had not been scientifically disapproved 

for ADDERALL XR as well as for other stimulants, the NDC made a series of recommendations, such as 

the ending of the suspension of the Notice of Compliance for ADDERALL XR. 

CZECH REPUBLIC 

___________________________________________________________________________ 

CZECH REPUBLIC - SUKL: Monthly Regulatory Update No 08, Aug-2005 

This document is laying down the most important regulatory news occured in Czech Republic in Aug-2005 

CZECH REPUBLIC - Vestnik SUKL No 08, Aug-2005 

Content of the SUKL Bulletin (Vestnik SUKL) 08/2005 

EUROPEAN UNION 

___________________________________________________________________________ 

EUROPEAN UNION - CHMP Positive Opinion EMEA/CHMP/227715/2005: The Granting of a 

Marketing Authorisation for NAGLAZYME (recombinant human N-acetylgalactosamine 4sulphatase 

(galsulfase)), 15-Sep-2005 

This document provides the CHMP Positive Opinion for the granting of a marketing authorisation for 

NAGLAZYME (recombinant human N-acetylgalactosamine 4-sulphatase (galsulfase)). NAGLAZYME was 

designated as an orphan medicinal product on 14 February 2001. 

- Applicant: BioMarin Europe Ltd. 

- Indications: NAGLAZYME is intended for long-term enzyme replacement therapy in patients with a 

confirmed diagnosis of Mucopolysaccharidosis VI (MPS VI; Nacetylgalactosamine 4-sulphatase 

(galsulfase) deficiency; Maroteaux-Lamy syndrome) to treat the clinical manifestations of the disease. 

The CHMP, on the basis of quality, safety and efficacy data submitted, considers that there is a 

favourable benefit to risk balance for NAGLAZYME and therefore recommends the granting of the 

marketing authorisation under exceptional circumstance.


Marketing Authorisation for PROQUAD (measles, mumps, rubella and varicella vaccine 

(live)), 15-Sep-2005 


PROQUAD (Measles, Mumps, Rubella and Varicella Vaccine (Live)). 

- Applicant: Sanofi Pasteur MSD. 

- Indications: PROQUAD is intended for simultaneous vaccination against measles, mumps, rubella and 

varicella. 


favourable benefit to risk balance for PROQUAD and therefore recommends the granting of the marketing 

authorisation. 


Marketing Authorisation for MACUGEN (pegaptanib sodium), 15-Sep-2005 


MACUGEN (pegaptanib sodium). 

- Applicant: Pfizer Ltd. 

- Indications: MACUGEN is indicated for the treatment of neovascular (wet) age-related macular 

degeneration (AMD). 


favourable benefit to risk balance for MACUGEN and therefore recommends the granting of the marketing 



Marketing Authorisation for YTTRIGA (yttrium (90Y) chloride), 15-Sep-2005 


YTTRIGA (yttrium (90Y) chloride). 

- Applicant: AEA Technology QSA GmbH, Germany. 

- Indications: YTTRIGA is intended for the radiolabelling of carrier molecules, which have been specifically 

developed and authorised for radiolabelling with this radionuclide. Yttriga is not intended for direct use in 

patients. 


favourable benefit to risk balance for YTTRIGA and therefore recommends the granting of the marketing 


EUROPEAN UNION - CHMP Referral Opinions EMEA/CHMP/145829/2005: Opinion following 

an Arbitration Pursuant to Article 29(2) of Directive 2001/83/EC for CRESTOR 5 mg 

(rosuvastatin calcium), 09-Aug-2005 

CRESTOR (rosuvastin calcium) is a selective 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) 

reductase inhibitor (statin) that has been approved for use as a lipid-regulating agent in the management 

of patients with dyslipidaemia. 

- On 07-Dec-2002 the MRP started;

- The arbitration procedure started 18-Nov-2004; 

- On 21-Apr-2005 CHMP adopted a positive opinion; 

- On 09-Aug-2005 the final opinion was converted into a Decision by the European Commission. 

This document is composed of: 

- Background Information, 

- Annex I: List of The Invented Names, 

- Annex II: Scientific conclusions 

- Annex III: Amended SPC of the RMS. 

EUROPEAN UNION - Commission Directive 2005/50/EC: Reclassification of Hip, Knee and 

Shoulder Joint Replacements in the Framework of Council Directive 93/42/EEC concerning 

Medical Devices, 11-Aug-2005 

By way of derogation from the rules set out in Annex IX to Directive 93/42/EEC (5925), hip, knee and 

shoulder replacements shall be reclassified as medical devices falling within class III. 

For the purpose of this Directive, a hip, knee or shoulder replacement means an implantable component 

part of a total joint replacement system which is intended to provide a function similar to that of either a 

natural hip joint, a natural knee joint or a natural shoulder joint. Ancillary components 

(screws, wedges, plates and instruments) are excluded from this definition. 

EUROPEAN UNION - Commission Regulation 1277/2005/EC: Laying down implementing 

Rules for European Parliament and Council Regulation 273/2004/EC on Drug Precursors and 

for Council Regulation 111/2005/EC laying down Rules for Monitoring of Trade between the 

Community and Third Countries in Drug Precursors, 27-Jul-2005 

This Regulation lays down rules for the implementation of Regulations 273/2004/EC (43156) and 

111/2005/EC (48687) as regards the responsible officer, the licensing and registration of operators, the 

provision of information, pre-export notifications and authorisation of exports and imports in the field of 

drug precursors. 

EUROPEAN UNION - Common Position 23/2005/EC: with a View to Adopting Directive 

2005/.../EC of the European Parliament and of the Council of ... on the Management of 

Waste from Extractive Industries and Amending Directive 2004/35/EC, 12-Apr-2005 

This Directive provides for measures, procedures and guidance to prevent or reduce as far as possible 

any adverse effects on the environment, in particular water, air, soil, fauna and flora and landscape, and 

any resultant risks to human health, brought about as a result of the management of waste from the 

extractive industries. 

EUROPEAN UNION - COMP Draft Positive Opinion EMEA/COMP/1289/2003: Public Summary 

of Positive Opinion for Orphan Designation of Thalidomide - Pharmion Developpement, 06- 

Sep-2005 

This document provides the COMP Public Summary of Positive Opinion for orphan designation of 

Thalidomide. 

- Applicant: Pharmion Developpement 

- Indications: for the treatment of graft versus host disease. 

EUROPEAN UNION - COMP Draft Positive Opinion EMEA/COMP/202020/2005: Public 

Summary of Positive Opinion for Orphan Designation of 4-Imino-1, 3-Diazobicyclo-[3.1.0]- 

Hexan-2-One, 11-Aug-2005

This document provides the COMP Public Summary of Positive Opinion for orphan designation of 4-Imino- 

1, 3-Diazobicyclo-[3.1.0]-Hexan-2-One. 

- Applicant: Icon Clinical Research (UK), Ltd 

- Indications: for the treatment of pancreatic cancer. 

EUROPEAN UNION - COMP Draft Positive Opinion EMEA/COMP/203896/2005: Public 

Summary of Positive Opinion for Orphan Designation of Adeno-Associated Viral Vector 

Containing Modified U7 snRNA Gene, 11-Aug-2005 

This document provides the COMP Public Summary of Positive Opinion for orphan designation of Adeno- 

Associated Viral Vector Containing Modified U7 snRNA Gene. 

- Applicant: Genethon, France; 

- Indications: for the treatment of Duchenne muscular dystrophy. 

EUROPEAN UNION - COMP Positive Opinion EMEA/167975/2005: Public Summary of 

Positive Opinion for Orphan Designation of Pegylated Arginine Deiminase, 26-Jul-2005 


pegylated arginine deiminase. 

- Applicant: F. Izzo, Italy 

- Indications: for the treatment of hepatocellular carcinoma. 

EUROPEAN UNION - COMP Positive Opinion EMEA/COMP/192749/2005: Public Summary of 

Positive Opinion for Orphan Designation of Human Monoclonal Antibody Against HLA-DR, 

26-Jul-2005 


Monoclonal Antibody Against HLA-DR. 

- Applicant: GPC Biotech AG, 

- Indications: for the treatment of Hodgkin’s lymphoma. 

EUROPEAN UNION - COMP Positive Opinion EMEA/COMP/42149/2005: Public Summary of 

Positive Opinion for Orphan Designation of Ciclosporin (inhalation use) for the Prevention of 

Graft Rejection After Lung Transplatation (Chiron Corporation Ltd), 01-Jul-2005 


Ciclosporin (inhalation use). 

- Applicant: Chiron Corporation Ltd, United Kingdom, 

- Indications: for the prevention of graft rejection after lung transplatation. 

EUROPEAN UNION - Court of Justice: Case C-276/05: Reference for a Preliminary Ruling 

from the Oberster Gerichtshof by Order of that Court of 24-May-2005 in The Wellcome 

Foundation Ltd. v Paranova Pharmazeutika Handels GmbH (Trade Marks) 

Subject: Trade Marks. 

EUROPEAN UNION - EMEA COMP Press Release EMEA/COMP/299233/2005: Sixtieth 

Meeting of the Committee for Orphan Medicinal Products, 14-Sep-2005

The Committee for Orphan Medicinal Products (COMP) held its 60th meeting on 8-9-Sep-2005. 

The Committee adopted twelve positive opinions on orphan medicinal product designation during this 

meeting. 

No negative opinion on orphan medicinal product was adopted. 

Annex 1: Medicinal products Designated as Orphan Medicinal Products since the July 2005 COMP 

Meeting. 

Annex 2: Overview of Procedures for Orphan Medicinal Product Designation for 2000-2004 

Annex 3: Overview of designated medicinal products that have been the subject or a centralised 

application for Marketing Authorisation. 

The next COMP meeting will be held on 19-Oct-2005. 

EUROPEAN UNION - EMEA Press Release EMEA/262135/2005: European Medicines Agency 

Consulting on a Draft Guideline on Pharmacovigilance for Medicines Used in Children, 12- 

Aug-2005 

This document informs that the European Medicines Agency (EMEA) has launched a six-month 

consultation period on a draft guideline on the conduct of pharmacovigilance for medicines used by the 

paediatric population, children from birth to 18 years of age. 

EUROPEAN UNION - EMEA/243280/2005: Practical Considerations on the Impact of the New 

Pharmaceutical Legislation on MA Applications via the Centralised Procedure and Centrally 

Authorised Medicinal Products for Human Use, 08-Sep-2005 

This guidance outlines practical considerations concerning the phasing in of Regulation (EC) No 

726/20041 and Directive 2004/27/EC2 to medicinal products for human use authorised or applied for via 

the centralised procedure. It provides an overview of those key-procedural elements affected by the new 

legislation, which will have an impact on ongoing applications or existing marketing authorisations, as 

appropriate. The guidance in this document represents the view of the EMEA, but the document does not 

have any legal force. In case of doubt reference is given to the above-mentioned Community Directive 

and Regulation. 

EUROPEAN UNION - EMEA/277378/2005: Draft Operational Procedure on Handling of 

"Consultation with Target Patient Groups" on Package Leaflets (PL) for Centrally Authorised 

Products for Human Use, 07-Sep-2005 

This guidance applies to centralised procedure applications concerning new medicinal products for human 

use, as of 20 November 2005. For ongoing applications, which are before day 120 on 20 November 2005, 

the required information needs to be provided by Day 121. For all other ongoing applications for which a 

marketing authorisation will be granted as of 20 November 2005, submission and review of the required 

information needs to be discussed with the EMEA on a case-by-case basis. Where significant changes are 

made to the package leaflet of authorised medicinal products, ‘user consultation’ should be considered on 

a case-by-case basis. 

EUROPEAN UNION - European Parliament Legislative Resolution: Proposal for a European 

Parliament and Council Regulation on Medicinal Products for Paediatric Use and Amending 

Regulation 1768/92/EEC, Directive 2001/83/EC and Regulation 726/2004/EC, 07-Sep-2005 

This document provides the European Parliament Legislative Resolution on the Commission Proposal 

COM(2004) 599 for a European Parliament and Council Regulation on Medicinal Products for Paediatric 

Use and Amending Council Regulation 1768/92/EEC (1613), Directive 2001/83/EC (37421) and 

Regulation 726/2004/EC (47587). In this Resolution, the European Parliament provides its Amendments

to the proposal. 

GREECE 

___________________________________________________________________________ 

GREECE - Communication of EOF: Timetable for the Submission of Applications for the 

Renewal of Marketing Authorizations of Pharmaceutical Products for Human Use that Expire 

on 31-Dec-2005, 05-Sep-2005 

By this communication EOF announces a daily timetable (52669), covering the first three weeks of 

October, for the submission of national renewal applications of pharmaceutical products for human use 

that expire on 31-Dec-2005, which mentions the exact date on which each company should submit its 

renewal application. 

Please also refer to: 

- 52676: Form for the Renewal Application of Products that Follow the National Procedure, Sep-2005 

- 52679: Form for the Non Renewal of Marketing Authorization of a Medicinal Product, Sep-2005 

- 52680: Form for the Withdrawal of the Packaging of a Pharmaceutical Product, Sep-2005 

GREECE - EOF Timetable for the Submission of National Renewal Application for Products 

whose Marketing Authorization expires by the end of 2005, Sep-2005 

This timetable comes with EOF Communication of 05-Sep-2005 (52664). It covers the first three weeks of 

October and mentions the exact date on which each company should submit its renewal application. 

Please also refer to: 

- 52676: Form for the Renewal Application of Products that Follow the National Procedure, Sep-2005 

- 52679: Form for the Non Renewal of Marketing Authorization of a Medicinal Product, Sep-2005 

- 52680: Form for the Withdrawal of the Packaging of a Pharmaceutical Product, Sep-2005 

GREECE - Form for the Non Renewal of Marketing Authorization of a Medicinal Product, Sep- 

2005 

This form in only provided in a PDF Format. Please go back to the PDF Document that is already in a 

ready-to-use format. 

Note: Depending on the version of Acrobat you are using, you may nedda more complete version to be 

able to save the form once completed. 

This form is to be filled in by the applicant who does not wish to renew the Marketing Authorization of a 

medicinal products. 

GREECE - Form for the Renewal Application of Products that Follow the National Procedure, 

Sep-2005 

This form is only provided in PDF Format. Please go back to the PDF document that is already in a readyto-use 

format. 

Note: Depending on the version of Acrobat you are using, you may need a more complete version to be 

able to save the form once completed.

This form is to be filled to apply for the renewal of the marketing authorization of medicinal products 

whose current MA expires by the end of 2005. 

GREECE - Form for the Withdrawal of the Packaging of a Pharmaceutical Product, Sep-2005 

This form is only provided in PDF Format. Please go back to the PDF document that is already in a readyto-use 

format. 

Note: Depending on the version of Acrobat you're using, you may need a more complete version to be 

able to save the form once completed.. 

This form is to be filled in by the applicant who wishes to withdraw the packaging of a pharmaceutical 

product. 

IRELAND 

___________________________________________________________________________ 

IRELAND - IMB: Important safety notice: Concerning Ayurvedic Medicinal Products found to 

contain High Levels of Heavy Metals, 18-Aug-2005 

The Irish Medicines Board (IMB) has recently learned that specific Ayurvedic medicinal products have 

been found to contain high levels of heavy metals such as mercury, arsenic and lead, in the United 

States. The products concerned are shown in the table in the document. 

JAPAN 

___________________________________________________________________________ 

JAPAN - PAB Notification No. 725: Enforcement of the Law for Partial Revision of the 

Pharmaceutical Affairs Law and the Adverse Drug Reaction Sufferings Relief Fund Law, 25- 

Aug-1993 

This document announces the matters implemented by the enforcement of the Law for Partial Revision of 

the Pharmaceutical Affairs Law and the Adverse Drug Reaction Sufferings Relief Fund Law (Law No. 27 in 

1993) The first section covers on priority evaluation and re-examination period. The definition of the 

product which is applied to the re-examination, the period and the outline of the re-examination are 

described. The second sections covers orphan medicinal product and orphan medical device designations. 

It describes the scope of orphan medicinal product and explains the application. The relevant application 

forms are included. 

The revisions of this document have been made. The last amendment is refered in PMSB Notification No. 

1324, 27 December 2000 (32564). 

PORTUGAL 

___________________________________________________________________________ 

PORTUGAL - Decree-Law 129/2005: Modification and Re-publication of the Decree-Law 

118/92 of 25-Jun-1992, 11-Aug-2005 

This Decree-Law modifies the articles 2 and 3 of the Decree-Law 118/92 (26093) laying down the 

reimbursement regimen by the State of the price of medicinal products. 

As a result of the government measures taken in the framework of health reforms and following the 

publication of the Ministerial Order 618-A/2005 (52727) setting up a 6% reduction in the price of the 

reimbursable medicinal products, this Decree-Law 129/2005 determines that the Scale A of the State 

reimbursement will be at 95% of the public price (PVP) of medicinal products. Special situations are also 

regulated in this Decree-Law.

The Decree-Law 118/92 of 25-Jun-1992 as last amended by Decree-Law 129/2005 is re-published in the 

Annex to this Decree-Law. 

PORTUGAL - Decree-Law 134/2005: Sale of Non Prescription Medicinal Products (OTC) out 

of Pharmacies, 16-Aug-2005 

This Decree-Law regulates the sale of non prescription medicinal products (OTC) out of pharmacies, in 

places that comply with the legal and regulatory requirements. 

The reimbursable OTCs are excluded from the provision above and will continue to be sold in pharmacies 

as their price and reimbursement is under control of the State. The OTC available out of pharmacies are 

subject to the same regimen of guaranty and taxation of quality and safety as medicinal products in 

pharmacies. 

The sale of medicinal products out of pharmacies can be done only by the pharmacist, technician or 

under pharmacist's supervision. Medicinal products sold under such conditions switch to a price freedom 

regimen, regulated by the rules of competition. 

This Decree-Law amends to the following regulatory texts: 

- Decree-Law 288/2001 of 10-Nov-2001; 

- Decree-Law 209/94 of 06-Aug-1994 (17541); 

- Decre-Law 135/95 of 09-Jun-1995 (16073); 

It repeals the Decree-Law 48 547 of 27-Aug-1968 (49919). 

PORTUGAL - Deliberation 957/2005: Harmonisation of Substances Terminology by the 

Portuguese Pharmacopoeia Committee, 24-Jun-2005 

The Portuguese Pharmacopoeia Committee (Comissão de Farmacopoeia Portuguesa) is a Specialised 

Technical Committee part of the INFARMED as described in Article 8.c) and Article 20.1.d) of Decree-Law 

495/99 (25121). 

A sub-committee created in 1997 entitled Terminology Harmonisation Sub-Committee prepared a "Listing 

containing proposals of common denominations in Portuguese of the active ingredients of medicinal 

products registered at the INFARMED", which was approved in June 1994. This listing contains: 

- Common Denomination in Portuguese (DCPt) of the International Common Denomination (or 

International Nonproprietary Names, I.N.N.) or Common Denomination of the active ingredients; 

- Order of active ingredients in pharmaceutical combinations of two substances; 

- Order of active ingredients in pharmaceutical combinations of three substances; 

- Order of active ingredients in pharmaceutical combinations of four subtances. 

The following annexes were also approved: 

- Annex I: General Practices used in the adaptation of INNs into Portuguese; 

- Annex II: Listings of most common prefixes/suffixes; 

- Annex III: Adaptation of annex III of "Guidelines on the use of International Nonproprietary Names 

(INNs) for pharmaceutical substances" of the WHO,

- Annex IV: Adaptation of annex IV of "Guidelines on the use of International Nonproprietary Names 

(INNs) for pharmaceutical substances" of the WHO, 

The above-mentioned listing approved in June 2004 is disclosed on the INFARMED website. 

This Deliberation 957/2005 was also published on the INFARMED website under Deliberation 

538/CA/2005. 

PORTUGAL - INFARMED Information Circular 094/CA (24-Aug-2005): Texts of SPCs and 

Package Leaflets Intended to be Delivered On-Line (Update to Information Circulars 120/CA 

of 30-Nov-2004 and 006/CA of 26-Jan-2005) 

This Information Circular is an update of Information Circulars 120/CA (47339) and 006/CA (48661) 

indicating to the MA applicants/holders the format for submissions of SPC and Patients Leaflets to the 

DMPS. 

The format of SPC and PL submitted to the DMPS must be: 

1. "word" format ("rtf" format prohibited), 

2. Fonts Arial or Times Roman, size 12; 

3. Justified paragraphs; 

4. Without header and footer; 

5. Without logotypes/watermarks; 

6. Without page/section breaks; 

7. Without tabulations, in any part of the text; 

8. Without page number; 

9. Use of a single format style all along the text, according to the previous items; 

10. When the use of symbols and/or Greek alphabet characters is necessary, proceed as follows: 

- Menu Insert, select Symbol, 

- Select Type of Letter " Symbol ", 

- Choose and insert the symbol and/or the chosen character. 

11. As much as possible, insert images or photos into a table to prevent any overwriting of the text. 

PORTUGAL - Ministerial Diffusion 19 650-A/2005: Pharmaco-therapeutic Groups Integrating 

the Medicinal Products Considered as Essential and Under the Application of the Article 3, 

Provision 6 of the Decree-Law 118/92 of 25-Jun-1992 (as amended), 01-Sep-2005 

This Ministerial Diffusion 19 650-A/2005 provides the pharmaco-therapeutic groups which integrate the 

medicinal products considered as essential in terms of life-saving and under the application of the 

provision 6, Art. 3 of Decree-Law 118/92 (26093), as amended by Decree-Law 129/2005 (52708). 

As a consequence of the reduced reimbursement rate of Scale A for reimbursable medicinal products, the 

provision 6, Art. 3 of the Decree-Law 118/92 still continue to reimburse at 100% the medicinal products 

of the pharmaco-therapeutic groups mentioned in the Annex to this Ministerial Diffusion.

This Ministerial Diffusion comes into force at the same date as Decree-Law 129/2005, namely September 

11th, 2005. 

PORTUGAL - Ministerial Order 618-A/2005: Price Update on Reimbursable Medicinal 

Products, 27-Jul-2005 

As a conclusion of the government measures in the framework of health reforms, this Ministerial Order 

updates the price of the reimbursable medicinal products by reducing the public price (PVP) of all 

medicinal products already approved at the date of the coming into force on September 15th, 2005 of 

this Ministerial Order by 6%. Measures for revisions of the prices according to different situations are 

described in this regulation. 

Wholesale and retail margins are also determined as following: 

- For wholesalers: 7,45% margin, calculated on the basis of the PVP after VAT deduction. 

- For retail pharmacies: 19,15% margin, calculated on the basis of the PVP after VAT deduction. 

This Ministerial Order suspends the provisions 5°, 6° and 9° of Ministerial Order 29/90 (26212) and 5° 

and 6° of Ministerial Order 577/2001 (29446). 

SPAIN 

___________________________________________________________________________ 

SPAIN - Circular 3/2005 from the AEMPS: Reduction of the Transmission Risk of the Variant 

of Creutzfeldt-Jakob Disease in Medicinal Products Including Human Blood or Plasma 

Derivatives as Active Ingredient, Excipient or During the Manufacturing Process, 27-Jul- 

2005 

This Circular 3/2005 provides instructions further to the measures on the reduction of the potential risk of 

transmission of the new variant of Creutzfeldt-Jakob disease, adopted through Circular 1/98 (16369) from 

the DGMPS and which deals with the aspects relative to the origin of the plasma. 

Holders of MA granted through national procedure should apply for a Type II Variation for medicinal 

products in which: 

- human blood/plasma (or any other derived product) is used in the manufacturing; 

- active ingredient is a product derived from human blood/plasma; 

- some of the excipients come from human blood/plasma or include one of them (or any other derived 

product) in the manufacturing. 

This variation corresponds to epigraph 400 MODIFICACIONES TYPE II referring to the Quality 

Documentation of the Circular 05/2004 from the AEMPS (44357). The variation must be adapted 

according to the Annex I to this Circular 3/2005 and the required documentation should be submitted 

before November 1st, 2005. 

SPAIN - Circular 4/2005 from the AEMPS: "Second Step" for the Use of the Plasma Master 

File Certificate, 27-Jul-2005 

In accordance with the EU Directive 2003/63/EC (39328) which introduces the concept of Plasma Master 

File (PMF) and a two-step procedure for the Plasma Master File Certificate (PMFC) of compliance with the 

EU legislation, the AEMPS provides this Circular 4/2005 as the "second step" of this procedure in which 

the AEMPS (competent authority) will grant a MA taking into account the certification, re-certification or 

variation of the PMF previously obtained through the centralised procedure.

The MA holders must follow the instructions in Annex I to this Circular that explain how to prepare the 

dossiers of PMFC to be sent to the AEMPS according to the situation that corresponds to them. The 

required documentation should be submitted before November 1st, 2005. 

UNITED STATES 

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UNITED STATES - Congressional Testimony: Statement of Richard Pazdur, M.D., CDER, on 

"Women and Cancer: Where Are We in Prevention, Early Detection and Treatment of 

Gynecologic Cancers?", 07-Sep-2005 

This testimony summarizes the recent FDA actions in order to improve oncologic drugs research: specific 

review processes to speed the development and approval of anti-cancer drugs (accelerated approval, 

priority review, fast track designation), specific workshop on endpoints related to various cancers, 

creation of an Interagency Oncology Task Force,... 

UNITED STATES - DHHS Press Release: Commissioners Selected for American Health 

Information Community, 13-Sep-2005 

On September 13, 2005, HHS Secretary Mike Leavitt selected 16 commissioners to serve on the American 

Health Information Community, a federally-chartered commission charged with advising the Secretary on 

how to make health information digital and interoperable. The work of the Community will help the 

country achieve the President’s goal of having most Americans using interoperable electronic health 

records within 10 years. Patients, doctors, hospitals and insurance companies will have access to vital 

and confidentiality-protected medical information immediately and efficiently, helping to reduce medical 

errors, improve quality, lower costs and eliminate paperwork hassle. 

The commissioners, from both private and public sectors, will serve two-year terms along with Advisors 

sought by the Secretary to provide subject matter expertise on issues identified by the Community. 

The meetings will be open to the public. 

(This document includes the Community Charter) 

UNITED STATES - DHHS Press Release: HHS Buys Vaccine and Antivirals in Preparation for a 

Potential Influenza Pandemic, 15-Sep-2005 

HHS Secretary Mike Leavitt announced the purchase of vaccine and antiviral medications that could be 

used in the event of a potential influenza pandemic. The department has awarded a $100 million contract 

to Sanofi Pasteur to manufacture avian influenza vaccine designed to protect against the H5N1 influenza 

virus strain which has caused an epidemic of avian flu in Asia. In addition, HHS has awarded a $2.8 

million contract to GlaxoSmithKline for 84300 treatment courses of the antiviral drug zanamivir (Relenza). 

These investments are part of a comprehensive U.S. approach to prepare for an influenza pandemic. 

UNITED STATES - DHHS Press Release: Statement by Mike Leavitt Secretary of Health and 

Human Services Regarding International Partnership on Avian and Pandemic Influenza 

United Nations General Assembly, 15-Sep-2005 

HHS Secretary Mike Leavitt affirms his commitment to the International Partnership on Avian and 

Pandemic Influenza and announces his leading an upcoming delegation from the U.S. to Thailand, 

Cambodia, Laos and Vietnam to seek critical involvement and personal commitment from these countries' 

Head of States and Ministers of Health. 

UNITED STATES - Draft Guidance for Industry and FDA Staff: Procedures for Handling Post- 

Approval Studies Imposed by PMA Order, 15-Sep-2005 

The draft guidance has two purposes. First, it is designed to aid sponsors who are subject to 

postapproval study requirements imposed by PMA order by providing specific recommendations on the 

information they should include when submitting their post-approval protocols and study results. Second,

the draft guidance is intended to increase the transparency of CDRH's approach to postapproval study 

requirements. The guidance discusses CDRH's plan to inform stakeholders of the status of post-approval 

studies by posting the status on the Internet. In addition, the guidance discusses opportunities for 

sponsors and CDRH staff to present the status of post-approval studies during the public meetings of the 

Advisory Panels that may have recommended approving the device with a condition that the sponsor 

conduct a post-approval study. 

UNITED STATES - Draft Guidance: PET Drug Products - Current Good Manufacturing Practice 

(CGMP), 01-Sep-2005 

A previous draft guidance has been published in March 2002 (33129). 

This draft guidance is intended to help PET drug producers better understand FDA’s thinking concerning 

compliance with the proposed CGMP regulations. The guidance addresses resources, procedures, and 

documentation for all PET drug production facilities, academic and commercial. In some cases, the 

guidance provides practical examples of methods or procedures that PET production facilities could use to 

comply with the proposed CGMP requirements. In developing this draft guidance, FDA has taken into 

consideration relevant issues, concerns, and questions raised at the public meetings held with 

professional associations, producers of PET drug products, and other interested parties. A first draft 

version of this guidance was issued in April 2002 (33129) in conjunction with revised preliminary draft 

proposed regulations (33177). 

UNITED STATES - Drug Approval Package: INCRELEX (mecasermin) - Approval Letter and 

Labeling, 30-Aug-2005 

This new drug application (NDA 21-839) provides for the use of INCRELEX (mecasermin [rDNA origin] 

injection) for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency 

(Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies 

to growth hormone. 

- Name of the medicinal product: INCRELEX 

- International Nonproprietary Name (INN): mecasermin 

- Applicant: Tercica, Inc. 

- Indications: Long-term treatment of growth failure in children 

- Pharmacotherapeutic class: Insulin like growth factor 1 

- Pharmaceutical form: Injection 

- Packaging: Vial 

- Route of administration: Injection, Subcutaneous use 

UNITED STATES - Drug Approval Package: NEVANAC (nepafenac) - Approval Letter and 

Labeling, 19-Aug-2005 

This new drug application (NDA 21-862) provides for the use of NEVANAC (nepafenac ophthalmic 

suspension) 0.1% for the treatment of pain and inflammation associated with cataract surgery 

- Name of the medicinal product: NEVANAC 

- International Nonproprietary Name (INN): nepafenac

- Applicant: Alcon, Inc. 

- Indications: Treatment of pain and inflamation associated with cataract surgery. 

- Pharmacotherapeutic class: Nonsteroidal Anti-inflammatory and Analgesic prodrug. 

- Pharmaceutical form: Ophthalmic suspension 

- Packaging: Bottle 

- Route of administration: Ophthalmic use, Ophthalmic suspension 

UNITED STATES - Endocrinologic and Metabolic Drugs Advisory Committee 

(Slides/Handouts): NDA 21-865: Paragluva (Muraglitazar), Bristol-Myers Squibb, 09-Sep- 

2005 

The Endocrinologic & Metabolic Drugs Advisory Committee (EMDAC) overwhelmingly recommended 

approval for Pargluva (muraglitazar) as monotherapy for the treatment of type 2 diabetes. On the subject 

of two different types of combination therapy for the treatment of the disease, the committee 

recommended approval for use of the drug with metformin and did not recommend the use of the drug 

in combination with sulfonylurea. 

Muraglitazar is the first of a new class termed "glitazars." Muraglitazar is an oxybenzylglycine, nonthiazolidinedione 

peroxisome proliferator-activated receptor (PPAR) dual agonist, active at both alpha and 

gamma PPAR receptors. 

The committee expressed concern about the occurrences of bladder cancer during the trials since the 

class of drugs to which muraglitazar belongs has well known bladder cancer results in rodent studies. The 

sponsor and FDA agreed that the mechanism involved in forming tumors in the bladders of rats is not 

applicable in humans and the four bladder cancer cases in the clinical studies for muraglitazar were 

probably not related to the study drug but will be monitored. 

There were also suggestions that patients with advanced cardiovascular conditions, edema, and 

hyperglycemia are at potentially higher risk from this drug product and should be given lower doses, and 

studies examining the effect of a 1.5 mg dosages were recommended. 

UNITED STATES - Endocrinologic and Metabolic Drugs Advisory Committee 

(Slides/Handouts): NDA 21-868: Exubera (Insulin Recombinant Deoxyribonucleic Acid 

[rDNA]) for Inhalation, Pfizer, Inc., 08-Sep-2005 

The Endocrinologic & Metabolic Drugs Advisory Committee (EMDAC) voted to recommend Exubera 

(insulin recombinant deoxyribonucleic acid [rDNA] origin powder for oral inhalation), for approval in the 

treatment of adults with diabetes. 

Exubera marks the first inhaled formulation of insulin. Increased comfort and satisfaction with the 

treatment administration is designed to increase compliance. 

The committee expressed concerns over the learning curve for the inhaler device, and asked the sponsor 

to give a better planned, detailed and complete training program for patients, and assurances that a full 

training would take place before product prescription. Other concerns about the device centered on 

compliance as the device is rather large and not portable. 

The sponsor was urged to conduct more studies on the effect of passive smoking. The committee also 

requested more long-term studies on lung disease, and pediatric and African-American studies, as both

populations are heavily impacted by diabetes and were under represented in the new drug application. 

UNITED STATES - FDA Enforcement Report, 14-Sep-2005 

List of recalls for the second week of September 2005. 

UNITED STATES - Federal Register: Agency Information Collection Activities; Proposed 

Collection; Comment Request; Pharmaceutical Development Study (Notice), 14-Sep-2005 

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the 

proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 

(the PRA), Federal agencies are required to publish notice in the Federal Register concerning each 

proposed collection of information and to allow 60 days for public comment in response to the notice. 

This notice solicits comments on a proposed Pharmaceutical Development Study. 

UNITED STATES - Federal Register: Agency Information Collection Activities; Proposed 

Collection; Comment Request; Reclassification Petitions for Medical Devices (Notice), 14- 

Sep-2005 

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the 

proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 

(the PRA), Federal agencies are required to publish notice in the Federal Register concerning each 

proposed collection of information, including each proposed extension of an existing collection of 

information, and to allow 60 days for public comment in response to the notice. This notice solicits 

comments on reclassification petitions for medical devices. 

UNITED STATES - Federal Register: Cardiovascular and Renal Drugs Advisory Committee; 

Notice of Meeting (Notice), 15-Sep-2005 

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug 

Administration (FDA). The meeting will be open to the public. 

Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. 

Date and Time: The meeting will be held on November 16, 2005, from 8 a.m. to 5 p.m. 

Location: Food and Drug Administration, CDER Advisory Committee Conference Room, rm. 1066, 5630 

Fishers Lane, Rockville, MD. 

Agenda: The committee will discuss new drug application (NDA) 21-628, proposed trade name CERTICAN 

(everolimus) Tablets (0.25 milligrams (mg), 0.50 mg, 0.75 mg, and 1.0 mg), Novartis Pharmaceuticals 

Corporation, for the proposed indication of prophylaxis of rejection in heart transplantation. 

UNITED STATES - Federal Register: Consumer-Directed Promotion of Regulated Medical 

Products; Public Hearing (Notice of public hearing, request for comments), 13-Sep-2005 

The Food and Drug Administration (FDA) is announcing a public hearing on direct-to-consumer (DTC) 

promotion of regulated medical products, including prescription drugs for humans and animals, vaccines, 

blood products, and medical devices. FDA is particularly interested in hearing the views of individuals and 

groups most affected by DTC promotion, including consumers, patients, caregivers, health professionals 

(physicians, physicians’ assistants, dentists, nurses, pharmacists, veterinarians, and veterinarian 

technicians) managed care organizations, and insurers, as well as the regulated industry. FDA is seeking 

input on a number of specific questions, but is interested in any other pertinent information participants 

in the hearing would like to share. 

UNITED STATES - Federal Register: Draft Guidance for Industry and Food and Drug 

Administration Staff; Procedures for Handling Post-Approval Studies Imposed by Premarket 

Approval Application Order; Availability (Notice), 15-Sep-2005

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled 

‘‘Procedures for Handling Post-Approval Studies Imposed by PMA Order.’’(52790) The draft guidance is 

designed to assist the Center for Devices and Radiological Health (CDRH) and sponsors to meet their 

responsibilities to track post-approval studies (sometimes called Condition of Approval Studies) that are 

mandated for market approval of medical devices. 

UNITED STATES - Federal Register: Guidance for Industry, FDA Staff, and FDA-Accredited 

Third Parties; Requests for Inspection by an Accredited Person Under the Inspections by 

Accredited Persons Program Authorized by the Medical Device User Fee and Modernization 

Act of 2002; Availability (Notice), 15-Sep-2005 

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Requests 

for Inspection by an Accredited Person under the Inspection by Accredited Persons Program Authorized 

by Section 201 of the Medical Device User Fee and Modernization Act of 2002.’’ (52804) The Medical 

Device User Fee and Modernization Act of 2002 authorizes FDA to establish a voluntary inspection 

program under which manufacturers of class II or class III devices who meet certain eligibility criteria as 

defined by the statute can elect to have FDA-accredited third parties conduct some of their establishment 

inspections instead of FDA. This guidance document describes the establishment eligibility criteria and the 

process for establishments to follow when requesting FDA’s approval to have an accredited person (AP) 

conduct an inspection of their establishment instead of FDA under the new Inspections by Accredited 

Persons Program (AP Program). 

UNITED STATES - Federal Register: Nonprescription Drugs Advisory Committee; Notice of 

Meeting (Notice), 15-Sep-2005 


Administration (FDA). At least one portion of the meeting will be closed to the public. 

Name of Committee: Nonprescription Drugs Advisory Committee. 

Date and Time: The meeting will be held on October 20, 2005, from 8 a.m. to 5:30 p.m., and on October 

21, 2005, from 8 a.m. to 12 noon. 

Location: Holiday Inn Washington Silver Spring, The Ballrooms, 8777 Georgia Ave., Silver Spring, MD. 

The hotel telephone number is 301–589– 0800. 

Agenda: The committee will discuss the benefits and risks of antiseptic products marketed for consumer 

use (e.g., antibacterial hand-washes and body-washes). The discussion will include topics such as the 

efficacy of antiseptics intended for use by consumers and potential risks to the individual and the general 

population from using these products. 

UNITED STATES - Federal Register: Pediatric Oncology Subcommittee of the Oncologic Drugs 

Advisory Committee; Notice of Meeting (Notice), 15-Sep-2005 


Administration (FDA). The meeting will be open to the public. 

Name of Committee: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. 

Date and Time: The meeting will be held on October 20, 2005, from 8 a.m. to 5 p.m. 

Location: Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Advisory 

Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.

Agenda: The subcommittee will do the following: (1) Present the structure and function of the Office of 

Oncology Drug Products in CDER, (2) discuss issues involved with the conduct of certain pediatric 

postmarketing studies for products approved for oncologic indications, (3) review status of studies for 

specific off-patent drugs for pediatric oncology, and (4) consider other off- patent oncology drugs for 

which pediatric studies are needed, as mandated by the Best Pharmaceuticals for Children Act. 

UNITED STATES - Guidance for Industry and FDA Staff: How to Write a Request for 

Designation (RFD) (Final), 01-Aug-2005 

This guidance is intended to clarify the type of information the Office of Combination Products (OCP) 

recommends that a sponsor include in a Request for Designation (RFD). The goal of this guidance is to 

help a sponsor understand the type of information FDA needs to determine the regulatory identity of a 

product as a drug, device, biological product, or combination product, and to assign the product to the 

appropriate agency component for review and regulation. This guidance reflects the final rule defining the 

primary mode of action of a combination product (PMOA Final Rule) published in the Federal Register on 

August 25, 2005 (52261). The PMOA Final Rule is effective November 23, 2005. 

UNITED STATES - Guidance for Industry, FDA Staff, and FDA-Accredited Third Parties: 

Requests for Inspection by an Accredited Person under the Inspection by Accredited Persons 

Program Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 

2002 (Final), 15-Sep-2005 

Current Version. A draft guidance has been published in June 2004 (47426). 

The AP Program applies to manufacturers who currently market their medical devices in the United States 

and who also market or plan to market their devices in foreign countries. These manufacturers may need 

current inspections of their establishments to operate in global commerce. 

One benefit of the new program is that it will allow manufacturers greater control over the timing of their 

inspections. In addition, because some of the APs accredited by FDA are already recognized by other 

countries as persons authorized to conduct inspections of device establishments, it is possible that in 

some cases a single AP inspection will meet the requirements of more than one regulatory authority, 

thereby reducing the need for multiple inspections of the same establishment. 

This guidance will help device establishments determine whether they are eligible to participate in the AP 

Program. Any establishment that is interested in obtaining additional information about eligibility or other 

matters addressed in this document may contact CDRH. Most of the APs who have been approved by 

FDA will have to complete training before they may begin conducting independent inspections under the 

new program. Therefore, many of the APs will not be available to companies for several months from the 

date of this guidance. 

UNITED STATES - Newsletter - AAC Consulting: Company Policies and Procedures for the 

Handling of FDA Inspections, Part I of II, 16-Sep-2005 

An FDA inspection is, for some, a very intimidating experience. But it can be much less traumatic if the 

company is prepared for the FDA Investigator and has established a set of policies and operating 

procedures that will govern employee behavior during the course of the inspection. 

In this week's newsletter from AAC Consulting, David Barr, a former Deputy Director at FDA's CDER 

(Center for Drug Evaluation and Research), and Anthony Celeste, formerly Director of FDA's ORO (Office 

of Regional Operations), review the areas that must be addressed when developing a policy on how to 

handle FDA inspections. 

UNITED STATES - Oncologic Drugs Advisory Committee (Briefing Information): NDA 21-491: 

Xinlay (Atrasentan Hydrochloride) Capsules, Abbott Laboratories, 13-Sep-2005 

The committee will discuss the new drug application (NDA) 21-491, proposed trade name XINLAY

(atrasentan hydrochloride) Capsules, Abbott Laboratories, proposed indication for the treatment of men 

with metastatic hormone-refractory prostate cancer. 

UNITED STATES - Oncologic Drugs Advisory Committee (Briefing Information): NDA 21- 

743/S003: Tarceva (Erlotinib) Tablets, OSI Pharmaceuticals Inc., 13-Sep-2005 

The committee will discuss the New Drug Application (NDA) 21-743, S003, TARCEVA (erlotinib) Tablets, 

OSI Pharmaceuticals Inc., proposed indication for the first-line treatment, in combination with 

gemcitabine, of patients with locally advanced, unresectable or metastatic pancreatic cancer. 


Arranon (nelarabine) Injection, GlaxoSmithKline, 14-Sep-2005 

The committee will discuss the NDA 21-877, proposed trade name ARRANON (nelarabine) Injection, 

GlaxoSmithKline, proposed indication for the treatment of patients with T-cell acute lymphoblastic 

leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to, or has relapsed with, 

at least two chemotherapy regimens. 


Revlimid (Lenalidomide), Celgene Corporation, 14-Sep-2005 

The committee will discuss the New Drug Application (NDA) 21-880, proposed trade name REVLIMID 

(lenalidomide), Celgene Corp., proposed indication for the treatment of patients with transfusiondependent 

anemia due to low or intermediate-1-risk myelodysplastic syndromes associated with a 

deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. 

UNITED STATES - Presentation: CBER Update: The Future is Now, 29-Aug-2005 

This presentation was made by Mary Malarkey, CBER, Director of the Office of Compliance and Biologics 

Quality, at the 10th Annual GMP by the Sea Conference - "Keeping the "c" in GMP", 29/31 August 2005. 

It gives an overview of the CBER challenges for the next years in the matter of counterterrorism; public 

health, especially prevention of pandemic risks, flu vaccine availability; cooperation with foreign agencies; 

Good Manufacturing and Tissue Practice, compliance programs... 

UNITED STATES - Press Release: FDA Statement: Theresa A. Toigo Is Appointed Acting 

Director of FDA's Office of Women's Health, 16-Sep-2005 

FDA Commissioner Lester M. Crawford announced the appointment of Theresa A. Toigo as the Acting 

Director of FDA's Office of Women’s Health. Ms. Toigo also serves as the Director of FDA’s Office of 

Special Health Issues (OSHI). 

UNITED STATES - Questions and Answers on Positron Emission Tomography (PET) Drugs 

Proposed CGMP Rule and Draft Guidance, 15-Sep-2005 

This Q&A document provides information to the public willing to comment on the proposed rule and 

revised draft guidance concerning PET drug CGMP requirements, both issued on September 15, 2005. 

PET drugs are radioactive drugs injected into patients that create images that can be read with a special 

camera. PET images show the chemical functioning of an organ or tissue, unlike X-ray or MRI images that 

show only body structure. PET imaging is useful for patients with certain conditions affecting the brain 

and the heart as well as in patients with certain types of cancer. 

UNITED STATES - Talk Paper: FDA Proposes Rule on Current Good Manufacturing Practices 

for Positron Emission Tomography (PET) Drugs, 15-Sep-2005 

The FDA is announcing a proposed current good manufacturing practices regulation for the production of 

Positron Emission Tomography (PET) drugs. The regulation, which establishes minimum standards for the 

production and testing of PET drug products, is intended to ensure that they meet the requirements of 

the Federal Food, Drug, and Cosmetic Act as to safety, identity, strength, quality, and purity.

Originally produced in academic institutions, PET drugs have increasingly become more commercialized 

and are today being reimbursed by private insurance plans. 

The proposed CGMP regulation is open for public comment for a 90-day period, after which the FDA will 

develop the final rule. Two years after that final rule takes effect, PET producers will be required to 

submit new drug applications before marketing a PET drug. 

UNITED STATES - US Reference Texts: Public Comments/Docket Number 2005D-0004 

This document lists the public comments on FDA "Draft Guidance for Industry: Nonclinical Safety 

Evaluation of Drug Combinations" (Docket No. 2005D-0004), received from pharmaceutical companies, 

public citizen groups and others in the drug industry. 

UNITED STATES - US Reference Texts: Public Comments/Docket Number 2005D-0103 

This document lists the public comments on FDA "Draft Guidance for Industry: Using a Centralized IRB 

Review Process in Multicenter Clinical Trials" (Docket No. 2005D-0103), received from pharmaceutical 

companies, public citizen groups and others in the drug industry. 

UNITED STATES - Vaccines and Related Biological Products Advisory Committee (Agenda): 

FDA Research Programs, 22-Sep-2005 

The committee will hear an overview of the research of the Laboratory of Retroviruses and the 

Laboratory of Immunoregulation, Division of Viral Products, and the Laboratory of Respiratory and Special 

Pathogens and the Laboratory of Methods Development and Quality Control, Division of Bacterial Parasitic 

and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and 

Research (CBER), and in closed session will discuss the reports from the Laboratory Site Visits of April 18 

and 19, 2005, and June 16, 2005. 

UNITED STATES - Vaccines and Related Biological Products Advisory Committee (Briefing 

Information): FDA Research Programs, 22-Sep-2005 






and 19, 2005, and June 16, 2005. 

UNITED STATES - Vaccines and Related Biological Products Advisory Committee (Roster): 

FDA Research Programs, 22-Sep-2005 






and 19, 2005, and June 16, 2005. 

UNITED STATES - Warning Letter: AM2 PAT, Inc. (dba Salient Health Care Technology), 11- 

Aug-2005 

An inspection conducted at AM2 PAT, Inc. in Raleigh, North Carolina revealed that the medical devices 

manufactured by this firm (prefilled syringes for intravenous catheter flushes) were adulterated as a 

consequence of significant violations of the Quality System Regulation. Nine such violations are reviewed 

in this warning letter. A July 2005 response from the firm was deemed partly adequate by the FDA who 

recommended verification of some of the corrective actions during a subsequent inspection.

UNITED STATES - Warning Letter: Beverly Hills Prosthetics Orthotics, Inc., 30-Aug-2005 

An inspection of Beverly Hills Prosthetics Orthotics Inc. in Los Angeles, CA, revealed that the devices 

manufactured by this firm (external assembly lower limb prostheses, limb orthoses and truncal orthoses) 

were adulterated as a consequence of significant violations of the Quality System Regulation. Five such 

violations are reviewed in this warning letter. The FDA also found that the devices were misbranded 

because their labeling lacked essential information and that the firm was no longer registered as a device 

establishment. Beverly Hills Prosthetics Orthotics has therefore been required to submit new forms 2891 

(Registration of Device Establishment) and 2892 (Device Listing) in addition to corrections to the above 

mentionned violations. 

UNITED STATES - Warning Letter: Enzymology Research Center, Inc., 18-Aug-2005 

An inspection conducted at Enzymology Research Center, Inc. in Miltona, Minnesota, revealed violations 

of the Federal Food, Drug and Cosmetics Act in the labels and labeling of the products manufactured, 

distributed and promoted by this firm (Re(in)Troduce Intestinal Bacteria, Re(inner)Gize Whole Food- 

Vitamin-Mineral, Re(in)Force II Therapeutic Enzyme, Digestive Enzyme and Protease VI Pure Proetolytic 

Enzymes). The FDA found that the claims contained in the promotional materials accompanying these 

products cause them to be (new) drugs as per section 201 of the Act. The distribution of these drugs 

therefore constitutes a violation of section 505 of the Act, as they are being marketed in the U.S without 

an approved NDA. Prompt action has been requested from the firm to correct these violations. 

UNITED STATES - Warning Letter: Michael S. Gottlieb, M.D. (Synergy Hematology-Oncology 

Associates); 23-Aug-2005 

An inspection conducted under CBER's Bioresearch Monitoring Program revealed violations of 21 CFR Part 

812 (Investigational Device Exemptions) in the clinical study of investigational devices conducted by Dr. 

Michael Gottlieb. Three such violations are reviewed in this warning letter, including: 

- failure to protect the rights, safety and welfare of the subjects under the clinical investigator's care, and 

to ensure that the investigation was conducted according to the signed investigator agreement, the 

investigational plan and applicable FDA regulations. 

- failure to maintain accurate, complete and current records relating to the receipt, use and disposition of 

devices 

- failure to maintain accurate, complete and current records of each subject's case history and exposure 

to the device. 

Prompt action has been requested from Dr. Gottlieb to correct the above deficiencies. 

UNITED STATES - Warning Letter: Octapharma USA, Inc., 31-Aug-2005 

CBER's OCBQ (Office of Compliance and Biologics Quality) reviewed a file card, a dosage guide and the 

website www.octapharma.com for the promotion of Octagam 5% [Immune Globulin Intravenous 

(Human)], and found these promotional material to be misleading because they fail to reveal material 

facts regarding the risks associated with Octagam and represent this product as safer and more effective 

than other drugs when this has not been proven. These promotional material therefore misbrand 

Octagam as per section 502 of the Federal Food, Drug and Cosmetic Act. 

OCBQ also found that Octapharma had failed to disseminate the file card with the PI (Product Labeling) 

and to submit the promotional material to the FDA at the time of initial dissemination, therefore violating 

21 CFR Part 601 (Biologics Licensing). 

Octapharma has been requested to cease the dissemination of violative promotional material and to 

submit a plan of action to disseminate truthful, non-misleading and complete information to the audience

that received the violative promotional material. 

UNITED STATES - Warning Letter: Oklahoma Blood Institute, 19-Aug-2005 

An inspection of the Oklahoma Blood Institute revealed violations of section 501 of the Federal Food, 

Drug and Cosmetic Act and of 21 CFR Parts 606 (CGMP for Blood and Blood Components) and 640 

(Additional Standards for Human Blood and Blood Products). The FDA reviews six such violations in this 

warning letter. Corrective actions from the firm were deemed adequate but untimely by the FDA who 

requested that the firm provide specific timelines for implementation of all the procedures and changes 

undertaken to correct the violations. 

UNITED STATES - Warning Letter: Universal Nutraceuticals, Inc., 22-Aug-2005 

An inspection of Universal Nutraceuticals Inc. in Rockville, Maryland and a review of the website 

www.universalnutraceuticals.com revealed that the product manufactured and distributed by this firm 

(Glucomet) was in violation of the Federal Food, Drug and Cosmetic Act because it was being marketed 

without prior FDA approval although the claims appearing on its labeling cause it to be a (new) drug as 

per section 201 of the Act. 

Prompt action has been requested from the firm to correct the above violation. 

For more information, please visit www.liquent.com 

Copyright ©2005 Liquent, Inc. 

A Thomson Company. 

All Rights Reserved. 

Copying, reproduction, retransmission, or redistribution, including by framing or similar means of any 

material contained in the DIA Global Regulatory Activity Digest in whole or in part or in any medium 

or form is prohibited without express permission. 

Drug Information Association, 800 Enterprise Road, Suite 200, Horsham PA USA 19044.

DIA Global Regulatory Activity Digest - Drug Information Association

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