Pharmaceutical Administration and Regulations in Japan - Nihs

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Table 5 Classification of Clinical Studies According to Objectives Type of study Objective of study Study examples Human • Assess tolerance pharmacology • Define/describe PK 1) and PD 2) • Dose-tolerance studies • Single and multiple dose PK and/or PD • Explore drug metabolism and drug studies interactions • Drug interaction studies • Estimate activity • ADME studies Therapeutic exploratory Therapeutic confirmatory Therapeutic use • Explore use for the targeted indication • Dose-response exploration studies • Provide basis for confirmatory study design, endpoints, methodologies • Demonstrate/confirm efficacy • Establish safety profile � Provide an adequate basis for assessing the benefit/risk relationship to support licensing • Refine understanding of benefit/risk relationship in general or special populations and/or environments • Identify less common adverse reactions • Refine dosing recommendation 1) Pharmacokinetics 2) Pharmacodynamics • Earliest studies of relatively short duration in well-defined narrow patient populations, using surrogate or pharmacological endpoints or clinical measures • Adequate, and well controlled studies to establish efficacy • Clinical safety studies • Large simple studies • Comparative effectiveness studies • Studies of mortality/morbidity outcomes • Large simple studies • Pharmacoeconomic studies 2011-3 - 129 -
Module 2 2.3: Quality overall summary Module 3 Quality 3.1: TOC Body of data Appendices Regional information Module 1 Administrative information: 1.1: NDA TOC 2.1: TOC 2.2: Introduction 2.4: Nonclinical Overview 2.6:nonclinical Written and Tabulated Summaries Module 4 Safety 4.1: TOC Study reports Literature references Fig. 9 Organization of ICH Common Technical Documents The Common Technical Document is organized into five modules. Module 1 is region specific. Modules 2, 3, 4, and 5 are intended to be common for all regions. Compliance with this guidance should ensure that these four modules are provided in a format acceptable to the regulatory authorities. http://www.nihs.go.jp/dig/ich/m4index-e.html 2.5: Clinical Overview 2.7: Clinical Summary Module 5 Efficacy 5.1: TOC Tabular listing of clinical studies Study reports & related info Literature references 2011-3 - 130 - N o n C T D C T D
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2011.3 INFORMATION IN ENGLISH ON JA
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Table of Contents CHAPTER 1 ···
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4.1 GMP Compliance Reviews ····
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TABLE 3 DATA TO BE SUBMITTED WITH A
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eliability of application data. Fol
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3) Control of household products co
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health care information-processing
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eevaluation of gastrointestinal dru
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contribution to drug research and d
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Ministry of Health, Labour, and Wel
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Committee on Japanese Pharmacopoeia
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CHAPTER 2 Pharmaceutical Laws and R
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11) (License standards, restriction
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of approvals and licenses, approval
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2) Classification according to hand
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(3) Quasi-drug marketing business l
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manufacturer submits an MF registra
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(4) On-site surveys for accreditati
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y testing facilities for nonclinica
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Implementation of Clinical Studies
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December 21, 2005. Based on this La
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Activities Encouraging Illicit Cond
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(7) General review conference (main
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diseases, a decision must be made w
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and use of drugs for pediatric use
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codevelopment group and requirement
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January 28, 2011 entitled “Issuan
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pharmaceutical excipients, physicoc
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application review of raw materials
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half of the 1980s and there were al
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Patent right 1 Patent right 2 Calcu
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Foreign manufacturer with manufactu
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Table. 1 List of Main Controlled Su
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Table. 2 Divisions of the Pharmaceu
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acceptance of the data is condition
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p) Consultations on compliance with
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http://www.pmda.go.jp/topics/file/
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Approval of Manufacturing/Marketing
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Summary of biopharmaceutics and ass
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1998 and partial revision by Office
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evised or established concerning ph
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are performed on the basis of the G
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Page 89 and 90: y made to Notification No. 813 of t
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Page 93 and 94: clinical exploration and developmen
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Page 97 and 98: dose not exceeding 1/100 of the dos
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Page 101 and 102: (21) Structure and Content of Clini
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Page 107 and 108: standards for the sponsoring of cli
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Page 111 and 112: PFSB dated October 1, 2008 and Offi
Page 113 and 114: trial sponsors (Article 59). Howeve
Page 115 and 116: e judged by personnel of the qualit
Page 117 and 118: standards, the Minister of Health,
Page 119 and 120: esults thereof. * Manufacturer, etc
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Page 123 and 124: carries out the duties set forth be
Page 125 and 126: in the two countries. These mutual
Page 127 and 128: PMSB dated February 22, 2000), Guid
Page 129 and 130: Information on approval reviews for
Page 131 and 132: Nonclinical studies Clinical studie
Page 133 and 134: (Table 3) Drug classification syste
Page 135: (Table 4) Drug classification syste
Page 139 and 140: Step 5* Q1A(R2) Q1B Q1C Q1D Q1E Q2
Page 141 and 142: Step 5* E1 Step 4* E2A Code E2B(M)
Page 143 and 144: 1998. Furthermore, a new guideline,
Page 145 and 146: supervisor, quality assurance super
Page 147 and 148: work is required and retention of c
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Page 151 and 152: etain these reports. [5] The safety
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Page 159 and 160: approval (known or unknown). g) Ser
Page 161 and 162: Information about adverse drug reac
Page 163 and 164: 6.2 Periodic Safety Reports (Articl
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Page 173 and 174: and the Role of the Regulatory Auth
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Page 179 and 180: 1.5 Entries for Biological Products
Page 181 and 182: 2.2 Pharmaceutical Interview Forms
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Labeling requirements of excipients
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No PMDA safety assessment team (5 t
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CHAPTER 6 Health Insurance Programs
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coverage was changed to 80% of medi
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OF DRUGS LISTED IN THE NHI DRUG PRI
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(excluding those in the JP) in the
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0212-(6) of the Health Policy Burea
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1998 Sept. 1997 5% 2% (Long listed
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Table 9. Requirements for Applying
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Within 60 days as a rule or 90 days
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Index 1 15-Day reports (ADR) ......
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Quality Standards and Government Ce
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(MHLW) Office of New Drug III (PMDA
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Specified biological products .....
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(Chapter 4) Kazuyo MARUCHI Product
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