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 Thomson, parent of the IDRAC regulatory database. 

*** NEW TEXTS THIS WEEK *** 

(From Monday, 06-Mar-2006 to Friday, 10-Mar-2006) 

These documents are available in the IDRAC database as of Tuesday, 14-Mar-2006. 

AUSTRALIA 

_____________________________________________________________ 

AUSTRALIA - Amendments to the Prescribing Medicines in Pregnancy 

Booklet, Feb-2006 

These amendments have been made to the 4th edition of the Prescribing Medicines in 

Pregnancy Booklet (30969). 

AUSTRALIA - Australian Drug Evaluation Committee: Gazettal Notice 

- Recommendations from the 244th Meeting held on 24-Fev-2006 

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. 

BELGIUM 

_____________________________________________________________ 

BELGIUM - DGMP Press Release (01-Mar-2006): LIFT Study with 

tibolone (LIVIAL - Organon) - Early Discontinuation Due to 

Increased Risk of Cerebrovascular Accidents (Dutch and French 

versions) 

Safety Information. 

The firm Organon decided, in February 23rd, 2006, on the basis of "Data safety Monitoring 

Board" recommendation, to discontinue prematurely the study called LIFT, a controlled 

study through placebo on the use of tibolone (LIVIAL) in the prevention of osteoporosisrelated 

vertebral fractures in menopausal women. 

The intermediary analysis of results has shown a increased incidence of cerebrovascular 

accidents in women who have taken tibolone (1,25 mg/day for 3 to 5 years) compared to 

women receiving placebo. The benefice-risk balance being not in favour of tibolone, it has 

been decided to stop the study. 

According to the SPC, LIVIAL is indicated in the case of oestrogens deficiency symptoms in 

menopausal women since more than 1 year, with a daily posology of 2,5 mg. Osteoporosis

is not an indication approved in Belgium. 

The current issue is to know if the LIFT study results concern the benefice-risk balance in 

the approved indication and posology in Belgium. This issue is under evaluation by the 

DGMP. 

BRAZIL 

_____________________________________________________________ 

BRAZIL - Order 94: Amendment of Order 593 of 25-Aug-2000 about 

the Internal Regimen of ANVISA, 08-Mar-2006 

This order amends Annex II of Order 593 of 25-Aug-2000 about the Internal Regimen of 

ANVISA (27709). It modifies articles 4 and 18 and adds articles 18-A and 18-B. 

This document modifies the structure of the ANVISA adding two committees: 

-Coordination Committee for Rational Use of Medicines 

-Advisory Committee of the Notification Pharmacy Program and adding their respective 

functions. 

CANADA 

_____________________________________________________________ 

CANADA - Dear Doctor Letter: Potential Risk of Cutaneous Vasculitic 

Toxicities associated with the use of HYDREA (hydroxyurea 

capsules), 01-Mar-2006 

This letter written by Bristol-Myers Squibb Canada focuses on Potential Risk of Cutaneous 

Vasculitic Toxicities associated with the use of HYDREA (hydroxyurea capsules) 

CANADA - External Working Group on the Registration and 

Disclosure of Clinical Trial Information (EWG-CT): Distribution List, 

29-Nov-2005 

Distribution list for the External Working Group on the Registration and Disclosure of Clinical 

Trial Information (EWG-CT). 

CANADA - Fact Sheet: Questions and Answers on Animal-Sourced 

Insulin, 28-Feb-2006 

Although the majority of patients with diabetes now use human insulin, there remains a 

small number of patients with diabetes who cannot manage their disease with biosynthetic 

insulins and are concerned over the bioavailability of animal-sourced insulin for the future. 

CANADA - Form: Intention to Invoke Section 37 of the Canada Food 

And Drugs Act for Products Being Exported 

This form focuses on the intention to invoke Section 37 of the Canada Food and Drugs Act 

(24022) for products being exported. 

This form is only provided in 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're using, you may need a more complete 

version to be able to save the form once completed.

For more information on Acrobat products, please refer to Adobe website: 

http://www.adobe.com 

CANADA - Health Canada Advisory: Diabetic Patients Are Advised Not 

to Use the Antibiotic TEQUIN, 16-Feb-2006 

Health Canada is advising diabetic patients, as a precaution, not to use the antibiotic Tequin 

due to concerns about blood glucose disorders. This advice is based on recommendations 

submitted to the department by the manufacturer of the drug, Bristol-Myers Squibb. 

CANADA - NHPD Quarterly Report Fall: 2005/Winter 2006, Feb-2006 

This Quarterly report is composed of 10 parts: 

- Message from the Director General 

- Full Steam Ahead: Moving Forward with the business Improvement Initiative 

- Information Sessions for the Ayurvedic Community 

- Status of Submissions 

- WHO consultation on the International Regulatory Cooperation of Herbal Medicines 

- Meeting-Mania 

- Update on the Public Opinion Research Initiative 

- Update on Clinical Trials - The Backlog is cleared! 

- Natural Health Product Raw Materials and Compounding Policies 

- Interim Measures to Facilitate Exportation of Natural Health Products 

CANADA - NHPD: Companies that Hold a Site Licence, as of 28-Feb- 

2006 

List of Canadian companies which hold a site licence for the manufacture of natural health 

products. 

CANADA - Notice of Decision: AVASTIN (bevacizumab), 16-Feb-2005 

On 09-Sep-2005, Health Canada issued a Notice of Compliance to Hoffmann-La Roche 

Limited for the drug product AVASTIN (bevacizumab), an antiangiogenic agent for use in 

combination with fluoropyrimide-based chemotherapy as first-line treatment for metastatic 

colorectal cancer. 

Based on the Health Canada review of data on quality, safety and effectiveness, Health 

Canada considers that the benefit/risk profile of AVASTIN is favourable when administered 

in combination with fluoropyrimide-based chemotherapy, under the conditions stated in the 

Product Monograph, for first-line treatment of patients with metastatic carcinoma of the 

colon or rectum. 

CANADA - Purchase of Licensed Medical Devices for Use in Dental 

Health Care, 25-Jan-2006 

This letter is being sent to remind dental health care practitioners that many types of 

medical devices used to deliver dental care to patients must comply with Canadian Medical 

Devices Regulations (47294). The Medical Devices Regulations prohibit dental laboratories 

or dental health care practitioners from importing certain types of medical devices (i.e., 

Class II, III and IV devices) that are not licensed in Canada. 

CANADA - Report on New Patented Drugs: TRAMACET 

This report focuses on the new patented medicinal product TRAMACET (tramadol 

HCI/acetaminophen) which is used for the short-term management of acute pain.

CANADA - Report on New Patented Drugs: AVASTIN 

This Report focuses on the new patented medicinal product AVASTIN (bevacizumab), which 

is used in combination with fluropyrimidine-based chemotherapy for first-line treatment of 

patients with metastatic carcinoma of the colon or rectum. 

CANADA - Report on New Patented Drugs: SENSIPAR 

This Report focuses on the new patented medicinal product Sensipar (cinacalcet 

hydrochloride) which is used for the treatment of secondary hyperparathyroidism in patients 

with Chronic Kidney disease (CKD). 

CANADA - Report: October-December 2005 Quarterly Drug 

Submission Performance Report, TPD, 09-Mar-2006 

This document contains the Quarterly Drug Submission Performance Report of TPD for the 

Fourth Quarter of 2005 (October-December). It contains statistics of Submissions Received 

and Final Outcomes, Appeals, Workload and Backlog and Performance. 

EUROPEAN UNION 

_____________________________________________________________ 

EUROPEAN UNION - CHMP Concept Paper 

EMEA/CHMP/BMWP/246511/2005: Developement of a Guideline on 

Immunogenicity Assessment of Therapeutic Proteins, 22-Feb-2006 

Current version, Deadline for Comments: 01-Jun-2006 

Treatment with therapeutic proteins may induce an immune reaction. Occasionally, this 

immune response is clinically significant. 

Although it is required to study possible unwanted immune reaction to therapeutic proteins 

before licensing, problems are still encountered after licensing. Thus far, CHMP has not 

given general guidance for the investigation and assessment of immunogenicity of 

therapeutic proteins. Obviously, guidance on the investigation and assessment of 

immunogenicity may contribute to a more rational and systematic approach to the 

immunogenicity by the industry and the regulatory authorities. 

PROPOSED TIMETABLE: Release for consultation on 23/02/06, deadline for comments 

31/05/06, discussion in BMWP 06/06 to 07/06 discussion with BWP 07/06, proposed date 

for release of draft guideline 07/06, deadline for comments 10/06, re-discussion in BMWP 

11/06 to 12/06, expected dated for adoption by Committee 01/07. 

EUROPEAN UNION - CHMP Concept Paper 

EMEA/CHMP/BPWP/9437/2006: Guideline on Comparability of 

Biotechnology-derived Medicinal Products after a Change in the 

Manufacturing Process: non-clinical and Clinical Issues, 22-Feb-2006 

Deadline for comments: 01-Jun-2006, This proposed guideline will replace guideline on 

comparability of medicinal products containing biotechnology-derived proteins as active 

substance (CPMP/3097/02) (42149) 

The existing guideline (CPMP/3097/02) addresses two situations: 

- When a change is introduced in the manufacturing process of a given product (either 

before the granting of a marketing authorisation or after the granting of a marketing

authorisation [variation procedure]). 

- When a product is claimed to be similar to another one already authorised in the EU after 

the expiry of the data protection period. 

The second part of the guideline relating to "similar" products is now redundant since the 

issue is addressed in the new guideline on similar biological medicinal (biosimilar) products 

containing biotechnology-derived proteins as active substance - (non) clinical issues 

(EMEA/CHMP/42832/2005). Thus, the old guideline CPMP/3097/02 will be withdrawn and 

the requirements for a comparability exercise supporting changes in the manufacturing 

process will be addressed in a new guideline. 

EUROPEAN UNION - CHMP Guideline 

EMEA/CHMP/BMWP/31329/2005: Biosimilar Medicinal Products 

Containing Recombinant Granulocyte-Colony Stimulating Factor/ 

Annex to Guid. on Similar Biological Medicinal Products Containing 

Biotechnology-Derived Proteins as Active Substance: Non-Clinical 

and Clinical, 22-Feb-2006 

Current version. Date for coming into effect: 01-Jun-2006. This final version replaces the 

draft version of May-2005 (51026). 

This document is an annex to the guideline on similar biological products containing 

biotechnology-derived proteins as active substance: non-clinical and clinical issues (56482). 

This guideline lays down the general requirements for demonstration of comparability of two 

recombinant human Granulocyte-Colony Stimulating Factor-containing medicinal products. 


EMEA/CHMP/BMWP/32775/2005: Similar Biological Medicinal 

Products Containing Recombinant Human Insulin/ Annex to Guid. on 

Similar Biological Medicinal Products Containing Biotechnology- 

Derived Proteins as Active Substance: Non-Clinical and Clinical 

Issues, 22-Feb-2006 



This Annex lays down the non-clinical and clinical requirements for soluble insulin containing 

products claiming to be similar to another one already marketed. 

The non-clinical section addresses the pharmaco-toxicological assessment. The clinical 

section addresses the requirements for pharmacokinetic, pharmacodynamic, efficacy and 

safety studies as well as the risk management plan. 



Products Containing Biotechnology-Derived Proteins as Active 

Substance: Non-Clinical and Clinical Issues, 22-Feb-2006 


draft version of May-2005 (50674).

This Guideline lays down the non-clinical and clinical requirements for a biological medicinal 

product claiming to be similar to another one already marketed. 

The non-clinical section addresses the pharmaco-toxicological assessment. The clinical 

section addresses the requirements for pharmacokinetic, pharmacodynamic, efficacy 

studies. The section on clinical safety and pharmacovigilance addresses clinical safety 

studies as well as the risk management This guideline addresses the general principles for 

the non-clinical and clinical development and assessment of the marketing authorisation 

applications of similar biological medicinal products containing recombinant proteins as 

active substance(s). This guideline does not address the comparability exercise for changes 

introduced in the manufacturing process of a given product (i.e. changes during 

development and post-authorisation). 



Products Containing Somatropin/ Annex to Guid. on Similar 

Biological Medicinal Products Containing Biotechnology-Derived 

Proteins as Active Substance: Non-Clinical and Clinical Issues, 16- 

May-2005 



This document is an annex to the draft guideline on similar biological products containing 

biotechnology-derived proteins as active substance: non-clinical and clinical issues (56482). 

This guideline lays down the general requirements for demonstration of comparability of two 

recombinant human somatropin-containing medicinal products. 


EMEA/CHMP/BWP/49348/2005: Similar Biological Medicinal 

Products Containing Biotechnology-Derived Proteins as Active 

Substance: Quality issues, 22-Feb-2006 


draft version of Mar-2005 (49338). 

This guideline addresses quality issues during demonstration of comparability for Similar 

Biological Medicinal Products (biosimilar products) containing recombinant DNA-derived 

proteins. As a consequence, the principles adopted and explained in this document should 

apply to proteins and peptides, their derivatives and products of which they are components 

(e.g. conjugates). For other situations see Guideline on Similar Biological Medicinal 

Products, CHMP/437/04. (53865). 

EUROPEAN UNION - CMD(h) Press Release: Report from the Meeting 

held on 20/21-Feb-2006 

General Issues: 

- CMD(h) Rules of Procedure 

- Role of the Vice-Chairperson of the CMD(h)

- Functions and Tasks for the CMD(h) 

- Procedure for adoption of lists of questions for Applications referred to the CMD(h) in 

accordance with Article 29(1) of Directive 2001/83/EC, as amended 

- CMD(h) Position on changing the Reference Member State 

- E-mail addresses for submission of translations in Mutual Recognition and Decentralised 

procedures 

- E-mail addresses for submission of electronic responses to the List of Questions for 

Applications referred to the CMD(h) in accordance with Article 29(1) of Directive 

2001/83/EC, as amended 

- Information on applications referred to the CMD(h) in accordance with Article 29(1) of 

Directive 2001/83/EC, as amended 

The next CMD(h) meeting will be held on 20/21/22-Mar-2006. 

EUROPEAN UNION - CMD(h): Contact E-Mail Addresses for 

Submission of Electronic Version of the Responses to the List of 

Questions for Applications Referred to the CMD(h), Feb-2006 

The list is provided to assist pharmaceutical companies identifying an email address for 

submission of electronic version of the response to the list of questions in each Member 

State. 

EUROPEAN UNION - CMD(h): Functions and Tasks, Feb-2006 

This document describes the CMD(h)'s functions and tasks. 

EUROPEAN UNION - CMD(h): Position on changing the Reference 

Member State, Revision 2, Mar-2006 

The CMD(h) agreed on a position to facilitate the process for a MAH, if a request for a 

change of the original Reference Member State should arise. 

EUROPEAN UNION - CMD(h): Rules of Procedure, Feb-2006 

This document defines the CMD(h) 's Rules of Procedure. 

EUROPEAN UNION - EMEA Press Release EMEA/84561/2006: 

European Medicines Agency Finalises Set of Guidelines on Similar 

Biological Medicines and Publishes Two more New Concept Papers, 

08-Mar-2006 

The European Medicines Agency published a set of five final guidelines on similar biological 

medicinal products. They are intended to give guidance to industry in the development of 

this new type of applications for marketing authorisation. 

EUROPEAN UNION - Heads of Medicines Agencies (HMA) - 

Homeopathic Medicinal Products Working Group (HMPWG): Draft 

Guidance on Module 3 of the Homeopathic Medicinal Products 

Dossier, Mar-2006 

Current version of the Guidance on Module 3 of the Homeopathic Medicinal Products

Dossier, Mar-2006 

The aim of this draft document is to provide guidance on the use of the NTA format when 

compiling an application dossier for homeopathic medicinal products. Moreover it is an 

attempt to harmonize the dossier template for homeopathic medicinal products to facilitate 

mutual recognition as laid down in the 2004/27/EC. 

Comments should be sent to homeo-nl@cbg-meb.nl by May-2006 

EUROPEAN UNION - Heads of Medicines Agencies (HMA) Press 

Release: Meeting Report of HMA in Vienna (Austria), 22/23-Feb- 

2006 

The EU Heads of Medicines Agencies (Human and Veterinary) held its first meeting under 

the Austrian Presidency in Vienna at Hilton Hotel, at 22nd and 23rd February 2006. 

The next meeting of Heads of Medicines Agencies will take place in Vienna, from 11/12 May 

2006. 

EUROPEAN UNION - Heads of Medicines Agencies (HMA): 

Harmonisation of Product Birthdates and Synchronisation of Periodic 

Safety Update Reports (PSURs) of Products Authorised through 

National or Mutual Recognition Procedures in the EU, 03-Jan-2006 

In this document, it is proposed that harmonised EU birth dates are set by mutual 

agreement between member states and the marketing authorisation holders of innovator 

products. PSUR submission throughout the EU will then be based upon these birth dates. 

Further details can be found in the two annexes. 

This document is composed of one letter and two annexes: 

- Annex 1: Towards Harmonised Birth Dates of Medicinal Products in the EU 

- Annex 2: Transitional measures for submission of PSURs for nationally authorised 

medicinal products for human and veterinary use. 

This document has been prepared by IDRAC by integrating the three files released in 

English by the HMA into one comprehensive document. Consequently, the page numbering 

is not in sequence, but has been left so that the user can appreciate the reorganisation done 

by IDRAC. It is also enriched by a Table of Contents provided in the left frame. 

EUROPEAN UNION - MRFG: Proposal for a Harmonised SPC for 

Influenza Vaccines, Revision 1, 01-Dec-2003 

Current Version. This document replaces the outdated version of 01-Oct-2001 (41121). 

The Pharmaceutical Committee has agreed with a proposal from the influenza vaccine 

manufacturers to use the Mutual Recognition Procedure, so that the review of the annual 

update of these products can follow a new specific and fast-track procedure in order to 

comply with 1998 regulatory requirements for pharmaceuticals (Directive 93/39). 

This harmonised SPC is intended solely for subunit and split virus vaccines. Whole cell 

vaccine or other types of influenza vaccines (including new developments) are not covered. 

EUROPEAN UNION - Pharmaceutical Committee: Summary Record of 

the 59th Meeting, 02-Dec-2005

The Pharmaceutical Committee met for the 59th time on 02-Dec-2005. 

The following issues were discussed: 

1. Implementation Review 2001 

2. Tissue engineering and advanced therapies 

3. Orphan medicinal products 

4. Pharmacovigilance 

5. International aspects 

6. A.O.B. 

- Counterfeit products 

- Flu pandemic 

- Withdrawal from the market of certain insulins 

EUROPEAN UNION - SOP EMEA/245906/2005: Annex I to 

SOP/EMEA/0029 - Template for Recording Top Management 

Decisions, 06-Mar-2006 

Current version 

This document provides a template for recording top management decisions. 

The following documents are also available: 

- SOP on Conducting the Annual Management review (56476); 

- Annex II - Checklist of mandatory input to annual management review (56460); 

- Annex III - Checklist of non-mandatory input to annual management (56462). 

EUROPEAN UNION - SOP EMEA/6310/2006: Annex II to 

SOP/EMEA/0029 - Checklist of Mandatory Input to Annual 

Management Review, 06-Mar-2006 

Current version 

This document provides a checklist of mandatory input to annual management review wich 

is intended to serve as a reminder. The list should be considered nonexhaustive. The 

relevant sector or unit is invited to complete the list by adding other reports that may need 

to feed into the management review to the checklist. 



- Annex I - Template for recording top management decisions (56459); 


EUROPEAN UNION - SOP EMEA/6322/2006: Annex III to 

SOP/EMEA/0029 - Checklist of Non-mandatory Input to Annual 

Management Review, 06-Mar-2006 

Current version

This document provides a Checklist of non-mandatory input to annual management review 

intended to serve as a reminder. The list should be considered nonexhaustive. The relevant 

sector or unit is invited to complete the list by adding other reports that may need to feed 

into the management review to the checklist. 



- Annex I - Template for recording top management decisions (56459); 

- Annex II - Checklist of mandatory input to annual management review (56460). 

EUROPEAN UNION - SOP/EMEA/0025: Conducting Internal Audits, 

Reporting Results and Follow-up, 07-Mar-2006 

Current version. This doument replaces the outdated SOP/EMEA/005 version dated 20-Oct- 

1999 (22274) 

The purpose of this SOP is to give guidance on the preparation of an audit plan, audit report 

and any follow-up actions. 

EUROPEAN UNION - SOP/EMEA/0029: Conducting the Annual 

Management review, 06-Mar-2006 

Current version. 

This SOP lists many of the various reporting elements which exist already and explains how 

they, and any other important reporting outcomes, should be channelled into the 

management review procedure, and thereby the annual planning and reporting cycle. 

The following annexes are also available: 

- Annex I - Template for recording top management decisions (56459) 

- Annex II - Checklist of mandatory input to annual management review (56460) 


FINLAND 

_____________________________________________________________ 

FINLAND - Administrative Regulation No. 1/2006: Laying down 

Principles and Detailed Guidelines for GCP as Regards 

Investigational Medicinal Products for Human Use, as well as the 

Requirements for Authorisation of the Manufacturing or Importation 

of such products, 13-Jan-2006 (Finnish and Swedish Versions) 

This administrative regulation No. 1/2006 implements the European Parliament and Council 

Directive 2001/20/EC (28709) and the Commission Directive 2005/28/EC (49720). The 

regulation does not include the sixth article (about Ethic committees) in the EU commission 

directive 2005/28/EC. The regulation is valid from 29-Jan-2006 up to 31-Jan-2011. 

FRANCE 

_____________________________________________________________ 

FRANCE - Decision of 16-Feb-2006: AFSSAPS Working Group on 

"Antibiotic Prophylaxis in Ocular Surgery" 

Creation, at the AFSSAPS, of a working group "antibiotic prophylaxis in ocular surgery".


Medicinal Products Used in Pneumology, Ophthalmology and 

Otorhinolaryngology (ENT) 

This decision repeals the decision DG 2003-66 of 23-Jun-2003 (25198). 

Creation of the AFSSAPS working group on medicinal products used in pneumology, 

ophthalmology and otorhinolaryngology (ENT). 


Rheumatological and Antalgic Medicinal Products, Except Those 

which Act on the Central Nervous System 

Creation of the AFSSAPS working group on rheumatological and antalgic medicinal products, 

except those which act on the central nervous system. 

FRANCE - Decision of 20-Feb-2006: Nomination of Experts to the 

Narcotics and Psychotropics Commission (Year 2006) 

This decision appoints, for the year 2006, the experts to the Narcotics & Psychotropics 

Commission. 

FRANCE - Decision of 20-Feb-2006: Nomination of Members of the 

AFSSAPS Working Group on Medicinal Products Used in Pneumology, 

Ophthalmology and Otorhinolaryngology (ENT) 

This Decision appoints the members of the AFSSAPS working group on medicinal products 

used in pneumology, ophthalmology and otorhinolaryngology (ENT). 

FRANCE - Decision of 20-Feb-2006: Nomination of Members of the 

AFSSAPS Working Group on Rheumatological and Antalgic Medicinal 

Products, Except Those which Act on the Central Nervous System 

This Decision appoints the members of the AFSSAPS working group on rheumatological and 

antalgic medicinal products, except those which act on the central nervous system. 

FRANCE - Decisions Relating to Promotional Bans (from January 

2006) 

This document concerns the promotional bans for medicinal products referred to in Art. L. 

5122-1 of the Public Health Code, intended for people qualified to prescribe, to supply or to 

use them in the practice of their art. 

- Decision 25-Jan-2006 

Flector Tissugel (Genevrier) 

- Decision 26-Jan-2006 

Nasonex (Schering-Plough) 

FRANCE - List of Pharmaceutical Companies which have Signed an 

Agreement with the Economic Committee for Health Products (CEPS) 

in 2005 (OJ 26-Feb-2006) 

This document provides the list of the 175 phamaceutical companies which have signed an 

agreement with the Economic Committee for Health Products (CEPS - Comité Economique

des Produits de Santé) in 2005. 

FRANCE - Ministry of Health Communication (23-Feb-2006): 

Therapeutic Benefit ("Service Medical Rendu") of Medicinal Products 

- New Evaluation 

Between 1999 and 2001, the Transparency Commission had identified 835 medicinal 

products with insufficient therapeutic value. The Ministry of Health announces the third step 

of the reevaluation procedure, concerning 141 products. 

INTERNATIONAL 

_____________________________________________________________ 

INTERNATIONAL - EDQM Guideline: Control Authority Batch Release 

of Meningococcal C Polysaccharide Protein Conjugate Vaccine, May- 

2002 (Revised Dec-2005) 

Current version. This document replaces EDQM Guideline: Control Authority Batch Release 

of Meningococcal C Polysaccharide Protein Conjugate Vaccine, May-2002 (Revised Dec- 

2004) (51291). 

This document provides information on: 

- the sampling and tests to be performed by the control laboratory for Meningococcal C 

Polysaccharide Protein Conjugate Vaccine, 

- the protocol submission, 

- the certification by qualified person taking overall responsibility for production and control 

of the product. 

This guideline came into force on 01-Jan-2005. 


of Meningococcal Polysaccharide Vaccine, Apr-1999 (Revised Dec- 

2005) 


of Meningococcal Polysaccharide Vaccine, Apr-1999 (Revised Dec-2004) (51305). 

This revised version includes revision to OMCL tests approved at the annual meeting of the 

OCABR network May 2003. 


- the sampling and tests to be performed by the control laboratory for Meningococcal 

Polysaccharide Vaccine, 


- the certification for production and control of the product. 

This revised guideline came into force on 01-Jan-2005. 


of Multivalent Pneumococcal Polysaccharide Conjugate Vaccine,

May-2002 (Revised Dec-2005) 


of Multivalent Pneumococcal Polysaccharide Conjugate Vaccine, May-2002 (Revised 2004) 

(51315). 


- the sampling and tests to be performed by the control laboratory for Multivalent 

Pneumococcal Polysaccharide Conjugate Vaccine,, 


- the certification by qualified person taking overall responsibility for production and control 

of the product. 

This guideline came into force on 01-Jan-2005. 


of Mumps Vaccine, Apr-1999 (Revised Dec-2005) 


of Mumps Vaccine, Apr-1999 (Revised 2004) (51319). 

This revised version includes editorial changes by EDQM to update guidelines with reference 

to Directive 2001/83/EC (31165). 


- the sampling and tests to be performed by the control laboratory for Mumps Vaccine, 



This revised guideline came into force on 01-Jan-2005. 


of Pneumococcal Polysaccharide Vaccine, Apr-1999 (Revised Dec- 

2005) 


of Pneumococcal Polysaccharide Vaccine, Apr-1999 (Revised Dec-2004) (51334). 

This revised version includes revisions to OMCL tests approved at the annual meeting of the 

OCABR network May 2003. 


- the sampling and tests to be performed by the control laboratory for Pneumococcal 

Polysaccharide Vaccine, 



This revised guideline came into force on Jan-2005.

JAPAN 

_____________________________________________________________ 

JAPAN - MHLW/MEXT Notice: Ethics Guideline for Epidemiological 

Research (Revision), 29-Jun-2005 

This document presents the current version of the Ethics Guideline for Epidemiological 

Research. This guideline defines matters to be observed by all those who are involved in 

epidemiological research, while taking the importance of epidemiological research in the 

maintenance and improvement of the nation's health and academic freedom into account. 

The scope of this guideline is epidemiological research which aims to investigate the cause 

and pathology of human diseases and establish methods of preventing and treating them. 

We expect all those involved in such epidemiological research to observe this guideline. 

JAPAN - PFSB/ELD Notification No. 0214001: Handling the 

Excipients Which Are Not Listed in the Japanese Pharmaceutical 

Excipients Directory, 14-Feb-2006 

This document presents the results of the field survey on the use of pharmaceutical 

additives which are not defined in the Dictionary of Pharmaceutical Additives (2000). This is 

summarized information that may be used as a reference for precedents for any future 

approval applications. 

JAPAN - Q&A: Approval for Foreign Manufacturers, 14-Feb-2006 

This document contains the Q&A on an approval for a foreign manufacturer which is 

regulated under the revised Pharmaceutical Affairs Law. The Q&A contains cover the status 

of an applicant, the timing of applying, attached documents, and deemed approval. 

MALAYSIA 

_____________________________________________________________ 

MALAYSIA - Guideline: Application for Variation of Registered 

Products 

This document presents a guideline on application for variation of registered products. The 

purpose of this guideline is to provide guidance to marketing authorization holders and 

applicants who intend to apply to vary the registered information of a registered product. 

The guideline defines the type of variations and outlines the supporting documents 

necessary for each type of variation. 

Type I: Minor variation within a 14 day period 

The marketing authorization holder may proceed to implement the change after the 14 day 

validation period upon the date of receiving the documents by the variation unit. Minor 

variations are subject to the conditions specified. 

For the interim period: 

An applicant may submit Type I variation manually together with the required documents by 

using the form specified. The manual submission must be submitted together with the 

online variation application. The approval will only be notified via online submission. 

Type II: Major Variation 

Type II variation is considered a major change and approval is required prior to 

implementation. The Marketing Authorization Holder is responsible for ensuring that all 

necessary validation has been conducted to demonstrate that the change does not reduce

the quality, safety and efficacy of the product. 

PORTUGAL 

_____________________________________________________________ 

PORTUGAL - INFARMED Information Circular 028/CA (06-Mar-2006): 

Document "Point to Consider on Non-Clinical Safety of Homeopathic 

Medicinal Products of Botanical, Mineral and Chemical Origin for 

Human Use" (Circular in Portuguese and Draft in English version) 

Homeopathic medicinal products of botanical, mineral and chemical origin for human use 

must warrant safety and need to be regulated according to the same non-clinical principles 

that are applied to other medicinal products. 

The document "Points to Consider on Non-Clinical Safety of Homeopathic Medicinal Products 

of Botanical, Mineral and Chemical Origin for Human Use", elaborated by the Homeopathic 

Medicinal Product Working Group of Competent Authorities, clarifies the framework and 

approach to be adopted during a non-clinical safety evaluation of homeopathic medicinal 

products of botanical, mineral or chemical origin. 

SPAIN 

_____________________________________________________________ 

SPAIN - AEMPS: Annex 4 - List of the Accredited Ethics Committees 

(CEICs) in Spain, Edition 04/2006 

This document provides the list with addresses and contacts of the ethics committees which 

should be contacted in case of clinical trial in each Autonomous Community in Spain. This 

document is the Annex 4 to the Spanish Clarifications on the Application of the Regulation 

on the Conduct of Clinical Trials with Medicinal Products for Human Use Since 01-May-2004, 

Version 3 (53161). 

SPAIN - Circular 02/2006 from the AEMPS: Information on the 

Resolutions from the Public Health Committee of the Council of 

Europe Regarding European Pharmacopoeia, 22-Jan-2006 (Circular 

in Spanish and Resolution from Public Health Committee in English 

version) 

This Circular 02/2006 informs of the decision through Resolution AP-CSP (06) 1 dated 06- 

Feb-2006 of the Public Health Committee (Partial Agreement) of the Council of Europe to 

withdraw from the European Pharmacopoeia the monograph "Limit test of particle size by 

microscopy (2.9.13)" at the date of 01-Jan-2007. 

The Resolution AP-CSP (06) 1 is appended to this Circular. 

SWITZERLAND 

_____________________________________________________________ 

SWITZERLAND - Swissmedic Communication: New Information on 

LIVIAL (tibolone), 16-Feb-2006 

This document only includes the German version. 

On 7 October 2005 Swissmedic informed about preliminary results of a placebo-controlled 

trial with the active ingredient tibolone (Long-Term-Intervention on Fractures with Tibolone, 

LIFT). The aim of this study was to assess the efficacy of tibolone on the vertebra fracture

ate in elderly women (mean age 68 years) with manifest osteoporosis. The results of this 

study were aimed to apply for an extension of indication for "treatment of osteoporosis". 

In the course of this study, the independent control organ (Data Safety Monitoring Board, 

DSMB) revealed in autumn 2005 a higher incidence of apoplexy after the first treatment 

years (2,4 years) in the tibolone group compared with the control group. After careful 

consideration of the risk/benefit ratio, the DSMB decided at that time to continue with the 

study. 

Now Swissmedic has received new information of the DSMB on behalf of the authorization 

holder, showing that an increased risk of apoplexia remains unchanged. Due to this fact the 

DSMB recommends to stop the LIFT study. No Swiss patients were included in this study. 

In this context, Swissmedic points out that a treatment with Livial (tibolone) should take 

place only after careful consideration of the individual risk/benefit ratio and that physicians 

should adhere to the approved indications and dosage recommendation. 

After obtaining the final study report, Swissmedic will evaluate the study results and decide 

if necessary risk-minimizing measures are to be taken. 

The physicians are requested to submit any adverse drug reactions under Livial to the 

regional pharmacovigilance centers. 

UNITED KINGDOM 

_____________________________________________________________ 

UNITED KINGDOM - Form: Application for a Wholesale Dealer's 

(General Sale List) Licence 

This form replaces the Application form for a Wholesale Dealer's (General Sale List) Licence 

(28717). 

Please note that a Wholesale dealer's (GSL) Licence allows the holder to wholesale deal 

General Sale List (GSL) medicines only. 

This document is ready-to-use form. 

UNITED KINGDOM - MHRA Form: Herbal or Homeopathic 

Registration 

This document is an MHRA Herbal or Homeopathic Registration Form. 

The ready-to-use form is available to the request. 

UNITED KINGDOM - MHRA Form: Marketing Authorisation 

Application (Version 7) 

Current version: This document replaces the Marketing Authorisation Application form 

(Version 5.1) (44307). 

For MA applications, this UK form can still be used but the new EU form (49354) can also be 

used providing additional UK requirements. 

This ready-to-use form is to be used for an Application for a Marketing Authorisation of a 

medicinal product for human use. Usually a separate application form for each strength and

pharmceutical form is required. For centrilised procedures a combined application form is 

acceptable. 

UNITED KINGDOM - MHRA Form: Notification of Intention to Import 

under the Medicines (Standard Provisions for Licences and 

Certificates) Amendment Regulations (SI 2005/2789) 

This document replaces the Notification of Intention to Import under the Medicines 

(Standard Provisions for Licences and Certificates) Amendment Regulations (SI 1999 No 4) 

(43336). 

This ready-to-use form is to be used for the MHRA notification of its intention to import an 

unlicensed relevant medicinal product in response to a bona fide unsolicited order to fulfil 

special needs, formulated in accordance with the specification of a doctor or dentist and for 

use by his individual patients on his direct personal responsibility and where the provisions 

set out in sub-paragraphs (2) to (9) of SI 2005 No 2789 (53805) are complied with. 

UNITED KINGDOM - MHRA: Directive on Traditional Herbal Medicinal 

Products - Guidance Notes on Arrangements for Companies to Give 

MHRA Advance Notice of Intended Applications, Nov-2005 

Current version: This document replaces the Directive on Traditional Herbal Medicinal 

Products - Guidance Notes on Arrangements for Companies to Give MHRA Advance Notice of 

Intended Applications, May-2004 (44548). 

The MHRA has introduced a voluntary arrangement under which companies are invited to 

give the Agency advance notice of their intention to submit applications for traditional use 

registration(s). 

The purpose of this arrangement is to enable the MHRA: 

- to plan effectively to meet likely workload and so provide an effective and efficient service 

to industry; and 

- to offer scientific and regulatory advice to companies in sufficient time to facilitate them 

make valid application(s). 

An template for companies to give MHRA advance notice of intended applications to register 

product(s) under the Directive on Traditional Herbal Medicinal Products is also available in 

ready-to-use form (44559). 

UNITED KINGDOM - MHRA: Directive on Traditional Herbal Medicinal 

Products - Transitional Arrangements, Dec-2005 

Current version: This document replaces the Directive on Traditional Herbal Medicinal 

Products - Transitional Arrangements, May-2004 (44549). 

This updated guidance has been prepared in response to a number of queries received by 

the MHRA about the application of transitional protection under the Directive on traditional 

herbal medicinal products. Please note that this guidance represents MHRA’s view and 

cannot be taken to be a definitive statement of the law. This can only be given by the 

courts. Where you have any doubts about your obligations, you should always consult your 

own professional advisors.

Any enquiries relating to the transitional arrangements or this note should be addressed to 

alison.daykin@mhra.gsi.gov.uk. 

UNITED KINGDOM - MHRA: Draft Application Form for 

Manufacturer's Authorisation Investigational Medicinal Products 

(MA(IMP)) 

This document replaces the Draft Application Form for Manufacturer's Authorisation 

Investigational Medicinal Products (MA(IMP)) (43148). 

This form is an application form for a manufacturer's authorisation - investigational 

medicinal product. 

To complete this form, please read the Guidance notes for completing an application form 

for a manufacturer's authorisation - investigational medicinal product (43151). 

This document is ready-to-use form. 

UNITED KINGDOM - MLX 322: Regulatory Fees for Medecines - 

Proposals for 1 April 2006, 28-Nov-2005 

This MLX 322 is a Proposals to amend MHRA fees for regulation of medicines (28469), 

homoeopathic products (4305) and medical devices (4874). All of these would only affect 

medicinal products for human use and proposed changes will be made through one 

Statutory Instrument. 

Comments on these proposals should be sent by 3rd February 2006. 

UNITED KINGDOM - SI 2006 No. 494: Explanatory Memorandum to 

the Fees and Charges Medecines: the Medicines for Human Use and 

Medical Devices (Fees Amendments) Regulations 2006, Feb-2006 

This document provides an Explanatory Memorandum to the Fees and Charges Medecines: 

the Medicines for Human Use and Medical Devices (Fees Amendments) Regulations 2006. 

SI 2006 No. 494: the Medicines for Human Use and Medical Devices (Fees Amendments) 

Regulations 2006 is also available (56490). 

UNITED KINGDOM - SI 2006 No. 494: the Medicines for Human Use 

and Medical Devices (Fees Amendments) Regulations 2006, 27-Feb- 

2006 

These Regulations make further amendments to the Medicines (Homoeopathic Medicinal 

Products for Human Use) Regulations 1994 (4305), the Medical Devices (Consultation 

Requirements) (Fees) Regulations 1995 (4874) and the Medicines (Products for Human Use- 

Fees) Regulations 1995 (28469). 

An Explanatory Memorandum to the Fees and Charges Medicines: the Medicines for Human 

Use and Medical Devices (Fees Amendments) Regulations 2006 is also available (56492). 

UNITED STATES 

_____________________________________________________________ 

UNITED STATES - Anti-Infective Drugs Advisory Committee (FDA 

Briefing Information): NDA 21-572/S-008: CUBICIN (daptomycin for

injection 500 mg/vial), Cubist Pharmaceuticals, 06-Mar-2006 

The committee discussed new drug application (NDA) 21-572/S-008, CUBICIN (daptomycin 

for injection 500 mg/vial), Sponsor Cubist Pharmaceuticals, for the proposed indication of 

the treatment of Staphylococcus aureus bacteremia, including those with known or 

suspected endocarditis caused by methicillin-susceptible and methicillin-resistant strains. 

The Committee recommended the approval of Cubist Pharmaceutical’s supplemental new 

drug application (sNDA) for CUBICIN (daptomycin) for the treatment of Staphylococcus 

aureus (S. aureus) bacteremia and infective endocarditis. One of the committee member’s 

major concerns was the development of increasing minimum inhibitory concentrations 

(MICs) to daptomycin during drug treatment. The increasing MICs were seen as tendencies 

and suggested further evaluation as well as labeling to provide surveillance for this effect. 

UNITED STATES - Anti-Infective Drugs Advisory Committee (Slides - 

Handouts): NDA 21-572/S-008: CUBICIN (daptomycin for injection 

500 mg/vial), Cubist Pharmaceuticals, 06-Mar-2006 











UNITED STATES - Anti-Infective Drugs Advisory Committee (Sponsor 

Briefing Information): NDA 21-572/S-008: CUBICIN (daptomycin for 

injection 500 mg/vial), Cubist Pharmaceuticals, 06-Mar-2006 











UNITED STATES - Blood Products Advisory Committee 

(Slides/Handouts): Day 1: Committee Updates, Rapid Tests for 

Detection of Bacterial Contamination of Platelets, Guidance on 

Collection of Platelets by Automated Methods; Day 2: Proposed 

Studies to Support Approval of OTC Homeuse HIV Test Kits, 09/10- 

Mar-2006 

On March 9, 2006, in the morning the committee will hear updates on the following topics:

(1) Summary of the Department of Health and Human Services Advisory Committee on 

Blood Safety and Availability January 2006 meeting; (2) current considerations for blood 

donor screening for West Nile Virus; (3) classification of transfusion recipient identification 

(ID) systems; and (4) summary of the workshop on behavior-based donor deferrals in the 

Nucleic Acid Test (NAT) era. The committee will then discuss rapid tests for detection of 

bacterial contamination of platelets. In the afternoon, the committee will discuss public 

comments on the "Guidance for Industry and FDA Review Staff: Collection of Platelets by 

Automated Methods (DRAFT)." 

On March 10, 2006, in the morning the committee will discuss proposed studies to support 

the approval of over-the-counter (OTC) home-use human immunodeficiency virus (HIV) test 

kits. In the afternoon, the committee will hear an overview of the research programs of the 

Office of Blood Research and Review, Center for Biologics Evaluation and Research (CBER), 

as presented to a subcommittee of the Blood Products Advisory Committee during their site 

visit on July 22, 2005, and discuss a subcommittee report in closed session. Additionally, 

the committee will hear an overview of the research programs in the Laboratory of 

Biochemistry and Vascular Biology and the Laboratory of Cellular Hematology, Division of 

Hematology, Office of Blood Research and Review, CBER and in closed session discuss the 

report from the laboratory site visit of October 6, 2005. 

UNITED STATES - Congressional Testimony: Statement by Anthony S. 

Fauci on Pandemic Influenza: The Road to Preparedness, 02-Mar- 

2006 

On March 02, 2006, Anthony Fauci, Director of the National Institute of Allergy and 

Infectious Diseases, testified before the U.S. House of Representatives Committee on 

Appropriations' Subcommittee on Foreign Operations, Export Financing and Related 

Programs about the H5N1 avian influenza, the threat of a human influenza pandemic and 

the research done at the National Institutes of Health to respond to seasonal influenza 

epidemics. (see also 56393 for the testimony of CDC's Julie Gerberding at the same 

hearing) 

UNITED STATES - Congressional Testimony: Statement by Julie L. 

Gerberding on Avian Influenza: Preparing for a Possible Influenza 

Pandemic, 02-Mar-2006 

On March 02, 2002, Julie Gerberding, Director of the Center for Disease Control and 

Prevention, testified before the U.S. House of Representatives Committee on Appropriations' 

Subcommittee on Foreign Operations, Export Financing and Related Programs about the 

CDC's response plan, including domestic surveillance and containment, should an influenza 

pandemic virus reach the United States. (see also 56387 for the testimony of NIAID's 

Anthony Fauci at the same hearing) 

UNITED STATES - Congressional Testimony: Statement of Bernard A. 

Schwetz (Office for Human Research Protections) on the Role of the 

HHS Office for Human Research Protections in Protecting Human 

Research Subjects, 07-Mar-2006 

On March 07, 2006, Bernard Schwetz, Director of the Office for Human Research Protections 

at the Department of Health and Human Services, testified before the U.S. House of 

Representatives Committee on Government Reform's Subcommittee on Criminal Justice, 

Drug Policy and Human Resources on the HHS' Protection of Human Subjects Regulations, 

in relation with human cloning and embryonic stem cell research issues. (see also 56516 

and 56517 for the testimonies of Chris Pascal, from the Office of Research Integrity, and

James Battey, from the NIH Stem Cell Task Force, at the same hearing) 

UNITED STATES - Congressional Testimony: Statement of Chris B. 

Pascal (Office of Research Integrity) on the Role of the HHS Office of 

Research Integrity in Investigating Research Misconduct, 07-Mar- 

2006 

On March 07, 2006, Chris Pascal, director of the Office of Research Integrity at the 

Department of Health and Human Services, testified before the U.S. House of 

Representatives Committee on Government Reform's Subcommittee on Criminal Justice, 

Drug Policy and Human Resources about research misconduct and the work of the Office of 

Research Integrity. (see also 56491 and 56517 for the testimonies of Bernard Schwetz from 

the Office for Human Research Protections and James Battey from the NIH Stem Cell Task 

Force at the same hearing) 

UNITED STATES - Congressional Testimony: Statement of James F. 

Battey (National Institutes of Health) on the Recent Events 

Concerning Stem Cell Research Fraud in South Korea, 07-Mar-2006 

On March 07, 2006, James Battey, Director of the National Institute on Deafness and Other 

Communication Disorders, and Chair of the National Institutes Of Health Stem Cell Task 

Force, testified before the U.S. House of Representatives Committee on Government 

Reform's Subcommittee on Criminal Justice, Drug Policy and Human Resources about the 

events concerning stem cell research fraud in South Korea, where the use of fake data and 

ethical violations are reported to have occured. (see also 56491 and 56516 for the 

testimonies of Bernard Schwetz, from the Office of Human Research Protections, and Chris 

Pascal, from the Office of Research Integrity, at the same hearing) 

UNITED STATES - Draft Guidance for Industry: Clinical Data Needed 

to Support the Licensure of Pandemic Influenza Vaccines, Mar-2006 

This document is intended to provide to you, sponsors of pandemic influenza vaccines, 

guidance on clinical development approaches to facilitate and expedite the licensure of 

influenza vaccines for the prevention of disease caused by pandemic influenza viruses. The 

approaches apply to "split virus" and whole virus inactivated pandemic vaccines propagated 

in embryonated chicken eggs, and are also applicable to cell-culture derived, recombinant 

hemagglutinin-based protein, and adjuvanted pandemic influenza vaccines. The FDA, also 

addresses live attenuated influenza vaccines. This document does not address influenza 

vaccines that do not contain a hemagglutinin component. Current U.S. licensed influenza 

vaccines are trivalent vaccines approved for the prevention of seasonal influenza illness. 

Two classes of vaccines are licensed, "split virus" trivalent inactivated vaccines and a live 

attenuated trivalent vaccine 

UNITED STATES - Draft Guidance for Industry: Clinical Data Needed 

to Support the Licensure of Trivalent Inactivated Influenza Vaccines, 

Mar-2006 

This document is intended to provide to you, sponsors of trivalent inactivated influenza 

vaccines, guidance on clinical development approaches to support a Biologics License 

Application (BLA). Currently two classes of trivalent vaccines are licensed in the United 

States, "split virus" inactivated trivalent vaccines and a live attenuated trivalent vaccine. In 

this document, the FDA, summarize clinical development approaches to facilitate and 

expedite the licensure of new "split virus" trivalent inactivated influenza vaccines, and they 

address both traditional and accelerated approval. These approaches are also applicable to

vaccines made with other manufacturing processes; e.g., whole virus inactivated, cellculture 

derived inactivated, recombinant hemagglutinin-based protein, and adjuvanted 

influenza vaccines. 

UNITED STATES - FDA Alert for Healthcare Professionals: 

Gatifloxacin (Marketed as TEQUIN), 07-Mar-2006 

This document contains a FDA alert on TEQUIN (gatifloxacin)'s labeling update to add 

warnings on hypoglycemia and hyperglycemia reports associated with TEQUIN treatment, a 

contraindication for diabetic patients, information on other risks factors for experiencing 

these adverse events and a recommendation for close monitoring of patients. It also 

contains additional considerations and a data summary on the blood sugar issues. 

UNITED STATES - FDA Enforcement Report, 08-mar-2006 

List of recalls for the second week of March 2006. 

UNITED STATES - Federal Register: Draft Guidance for Industry on 

Clinical Data Needed to Support the Licensure of Pandemic Influenza 

Vaccines; Availability (Notice), 10-Mar-2006 

The Food and Drug Administration (FDA) is announcing the availability of a draft document 

entitled ‘‘Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic 

Influenza Vaccines,’’(56472) dated March 2006. The draft document is intended to provide 

to sponsors of pandemic influenza vaccines guidance on clinical development approaches to 

facilitate and expedite the licensure of influenza vaccines for the prevention of disease 

caused by pandemic influenza viruses. The draft guidance provides recommendations for 

clinical data to support biologics license application (BLA) license approval either as a 

supplement or as a new BLA using the accelerated approval pathway. 

UNITED STATES - Federal Register: Draft Guidance for Industry on 

Clinical Data Needed to Support the Licensure of Trivalent 

Inactivated Influenza Vaccines; Availability (Notice), 10-Mar-2006 

The Food and Drug Administration (FDA) is announcing the availability of a draft document 

entitled ‘‘Guidance for Industry: Clinical Data Needed to Support the Licensure of Trivalent 

Inactivated Influenza Vaccines,’’ (56471) dated March 2006. The draft guidance document 

is intended to provide to sponsors of trivalent inactivated influenza vaccines guidance on the 

clinical data needed to support a Biologics License Application (BLA). The draft guidance 

summarizes clinical development approaches to facilitate and expedite the licensure of new 

trivalent inactivated influenza vaccines and addresses both traditional and accelerated 

approval. 

UNITED STATES - Federal Register: Guidance for Industry and Food 

and Drug Administration; Hospital Bed System Dimensional and 

Assessment Guidance to Reduce Entrapment; Availability (Notice), 

10-Mar-2006 

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

entitled ‘‘Hospital Bed System Dimensional and Assessment Guidance to Reduce 

Entrapment.’’(56529) This guidance provides recommendations intended to reduce lifethreatening 

entrapments associated with hospital bed systems. It characterizes the body 

parts at risk for entrapment, identifies the locations of hospital bed openings that are 

potential entrapment areas, recommends dimensional criteria for bed systems, provides 

information about legacy beds including information to include when reporting entrapment

adverse events, and provides the Hospital Bed Safety Workgroup (HBSW) test methods for 

assessing gaps. 

UNITED STATES - Federal Register: Industry Exchange Workshop on 

Food and Drug Administration Clinical Trial Requirements; Public 

Workshop (Notice of public workshop), 07-Mar-2006 

The Food and Drug Administration (FDA), Baltimore District, in cooperation with the Society 

of Clinical Research Associates (SoCRA), is announcing a workshop on FDA clinical trial 

statutory and regulatory requirements. This 2-day workshop for the clinical research 

community targets sponsors, monitors, clinical investigators, institutional review boards, 

and those who interact with them for the purpose of conducting FDA regulated clinical 

research. The workshop will include both industry and FDA perspectives on proper conduct 

of clinical trials regulated by FDA. 

UNITED STATES - Federal Register: Pediatric Advisory Committee; 

Amendment of Notice (Notice), 10-Mar-2006 

The Food and Drug Administration (FDA) is announcing an amendment to the notice of 

meeting of the Pediatric Advisory Committee. This meeting was announced in the Federal 

Register of February 1, 2006 (71 FR 5343) (55550). The amendment is being made to 

reflect a change in the Date and Time and Agenda portions of the document. The starting 

time of the meeting has been moved to 7:30 a.m. and the committee will now also hear and 

discuss information on cardiovascular adverse events possibly related to ADHD medications. 

There are no other changes. 

UNITED STATES - Federal Register: Report on the Performance of 

Drug and Biologics Firms in Conducting Postmarketing Commitment 

Studies; Availability (Notice), 03-Mar-2006 

The Food and Drug Administration (FDA) is required, under the Food and Drug 

Administration Modernization Act of 1997 (Modernization Act), to report annually in the 

Federal Register on the status of postmarketing study commitments made by sponsors of 

approved drug and biological products. This is the agency’s report on the status of the 

studies sponsors have agreed to or are required to conduct. 

UNITED STATES - Guidance for Industry and FDA Staff: Hospital Bed 

System Dimensional and Assessment Guidance to Reduce 

Entrapment (Final), 10-Mar-2006 

Current Version. A draft guidance has been published in August 2004 (47432). 

This guidance provides recommendations relating to hospital beds and hospital bed 

accessories. The guidance provides recommendations intended to reduce life-threatening 

entrapments associated with hospital bed systems. It characterizes the body parts at risk 

for entrapment, identifies the locations of hospital bed openings that are potential 

entrapment areas, and recommends dimensional criteria for these devices. 

UNITED STATES - Medication Guide: ADVAIR DISKUS (fluticasone 

propionate and salmeterol inhalation powder), 03-Mar-2006 

This medication guide presents the drug ADVAIR DISKUS (fluticasone propionate and 

salmeterol inhalation powder), the most important information about the drug, its 

indications, precautions of use, use directions, possible adverse effects, storage

ecommendations and instructions for use. 

UNITED STATES - Medication Guide: SEREVENT DISKUS (salmeterol 

xinafoate inhalation powder), 03-Mar-2006 

This medication guide presents the drug SEREVENT DISKUS (salmeterol xinafoate inhalation 

powder), the most important information about the drug, its indications, precautions of use, 

use directions, possible adverse effects, storage recommendations and instructions for use. 

UNITED STATES - National Institute of Health (NIH) Press Release: 

Evaluation of Patients Treated With Natalizumab Finds No New 

Cases of Progressive Multifocal Leukoencephalopathy, 01-Mar-2006 

The National Institute of Health (NIH) announces the results of an independent clinical and 

laboratory safety study of patients treated during clinical trials for multiple sclerosis, Crohn's 

Disease and rheumatoid arthritis with TYSABRI (natalizumab), a drug approved in 

November 2004 for treatment of relapsing-remitting multiple sclerosis (MS). This study was 

undertaken for the laboratory part by the National Institute of Neurological Disorders and 

Stroke (NINDS) to assess the risk for progressive multifocal leukoencephalopathy (PML) 

after TYSABRI's withdrawal from the market and clinical trials in February 2005 after the 

identification of three PML cases. The study did not identify additional cases but the risk for 

future development of PML in examined patients as well as the risk associated with longterm 

treatment remain unknown. 

UNITED STATES - Patient Information Sheet: Gatifloxacin (Marketed 

as TEQUIN), 07-Mar-2006 

This document presents the drug TEQUIN (gatifloxacin), its contraindications, main adverse 

effects, precautions of use, possible interactions with drugs or food and additional 

information. It also contains an alert on TEQUIN's labeling update to warn about serious 

blood sugar problems associated with some TEQUIN patients. 

UNITED STATES - Peripheral and Central Nervous System Drugs 

Advisory Committee (Agenda and Questions): BLA 125104/S-015: 

TYSABRI (natalizumab), Biogen Idec Inc, 07/08-Mar-2006 

The committee discussed TYSABRI (natalizumab) biologic license application 125104/15; 

Biogen Idec Inc., for an indication in patients with relapsing forms of multiple sclerosis to 

reduce the frequency of clinical exacerbations. The committee will discuss the risks 

(including progressive multifocal leukoencephalopathy) associated with TYSABRI 

(natalizumab) administration, its efficacy in the treatment of multiple sclerosis relapses 

and/or disability, its possible return to the marketplace, and its proposed risk management 

plan(s). 

UNITED STATES - Peripheral and Central Nervous System Drugs 

Advisory Committee (Briefing Information): BLA 125104/S-015: 

TYSABRI (natalizumab), Biogen Idec Inc, 07/08-Mar-2006 

The committee discussed TYSABRI (natalizumab) biologic license application 125104/15; 

Biogen Idec Inc., for an indication in patients with relapsing forms of multiple sclerosis to 

reduce the frequency of clinical exacerbations. The committee will discuss the risks 

(including progressive multifocal leukoencephalopathy) associated with TYSABRI 

(natalizumab) administration, its efficacy in the treatment of multiple sclerosis relapses 

and/or disability, its possible return to the marketplace, and its proposed risk management

plan(s). 

UNITED STATES - Press Release: FDA Warns Manufacturers About 

Illegal Steroid Products Sold as Dietary Supplements, 09-Mar-2006 

The Food and Drug Administration (FDA) announces the sending of warning letters to the 

manufacturers and distributors of unapproved medicinal products marketed as anabolic 

steroid dietary supplements, considered by the agency to cause long-term adverse events 

such as liver toxicity, male testicular atrophy, breast enlargment and infertility, 

masculinization of women, child short stature, blood lipid level issues and an increased risk 

for heart attack and stroke. 

UNITED STATES - Preventing Tetanus, Diphtheria, and Pertussis 

Among Adolescents: Use of Tetanus Toxoid, Reduced Diphtheria 

Toxoid and Acellular Pertussis Vaccines: Recommendations of the 

Advisory Committee on Immunization Practices (ACIP), 23-Feb-2006 

This document reviews vaccine availability and vaccination policies in the U.S. for pertussis, 

tetanus and diphtheria in children, children and adolescents and adults. It details the 

pertussis, tetanus and diphtheria general clinical characteristics, pertussis clinical features 

and morbidity among adolescents, diagnosis, incidence and outbreaks among adolescents. 

It presents the approval criteria and detailed information on the two Tdap products 

approved for immunization of adolescents and adults against these diseases, BOOSTRIX and 

ADACEL. It considers several studies: a clinical efficacy study of an adolescent and adult 

acellular pertussis (ap) vaccine with the same pertussis antigens included in BOOSTRIX, a 

study of the economic impact of pertussis and economic studies on adolescent vaccination 

strategies. After mentioning other Diphtheria Toxoids, Adsorbed for Adult Use (Td) or 

tetanus toxoid (TT) vaccines approved for patients older than 7 years-old, it reviews the 

Tdap or Td safety data: the main detected adverse events, studies on the spacing and 

administration sequence of Tdap/Td vaccines and studies on the simultaneous / sequential 

vaccination with Tdap and MENACTRA (MCV4). It considers the ACIP recommendations 

regarding the neurologic and systemic adverse events associated with pertussis-component 

containing vaccines, the Guillain-Barré syndrome associated with tetanus-toxoid containing 

vaccines and the vaccination of pregnant adolescents. It ends with the summary of the 

rationale for adolescent Tdap recommendations, the detailed recommendations for use of 

Tdap and Td in adolescents, vaccine adverse event reporting directions with a presentation 

of the National Vaccine Injury Compensation Program (VICP) and areas for future research. 

UNITED STATES - Public Comment/Docket No. 2002D-0492 

(formerly 02D-0492): GlaxoSmithKline (GSK), 01-Apr-2003 

This document contains the public comments from GSK on the FDA Draft Guidance: 

"Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in 

Adult Healthy Volunteers" (36955). FDA announced the availability of this guidance in the 

Federal Register on January 16, 2003 (Volume 68, Number 11)) (36954). The scope of this 

guidance is to outline a process (algorithm) and vocabulary for deriving the maximum 

recommended starting dose (MRSD) for "first in human" clinical trials of new molecular 

entities in adult healthy volunteers and recommends a standardized process by which the 

MRSD can be selected to ensure the safety of the human volunteers. 

UNITED STATES - Public Comment/Docket No. 2002D-0492 

(formerly 02D-0492): Human Genome Sciences, Inc (HGSI) 01-Apr- 

2003 

This document contains the public comments from GSK on the FDA Draft Guidance:

"Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in 

Adult Healthy Volunteers" (36955). FDA announced the availability of this guidance in the 

Federal Register on January 16, 2003 (Volume 68, Number 11)) (36954). The scope of this 

guidance is to outline a process (algorithm) and vocabulary for deriving the maximum 

recommended starting dose (MRSD) for "first in human" clinical trials of new molecular 

entities in adult healthy volunteers and recommends a standardized process by which the 

MRSD can be selected to ensure the safety of the human volunteers. 

UNITED STATES - Warning Letter: Oculus Optikgerate GmbH, 21- 

Feb-2006 

An inspection of Oculus Optikgerate GmbH in Wetzlar, Germany, revealed that the medical 

devices manufactured by this firm (Pentacam and Pachycam) were adulterated as a 

consequence of violations of the Quality System regulation (21 CFR Part 820). Three 

violations are reviewed in this warning letter. 

UNITED STATES - Warning Letter: Thomas P. Gross, M.D. (Midlands 

Orthopedic Group, LLC), 24-Feb-2006 

An inspection of Dr. Thomas Gross' clinical site in Irmo, South Carolina, revealed violations 

of 21 CFR Parts 812 (Investigational Device Exemptions) and 50 (Protection of Human 

Subjects) in the clinical trial of investigational study conducted by Dr. Gross. Four violations 

are reviewed in this warning letter. 

For more information, please visit www.liquent.com 

Copyright ©2006 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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