Pharmaceutical Administration and Regulations in Japan - Nihs

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Step 2* Step 1* Step 5* Step 4* Step 3* Step 2* Step 1* Quality Code Code Code Q4B (Annex 13) Q4B (Annex 14) Q3C(R5) Q11 Q3D S1A S1B S1C(R2) S2A S2B S3A S3B S4 S5(R2) S6 S7A S7B S8 S9 S2(R1) S6(R1) Bulk density and tapped density of powders Bacterial endotoxins test Guideline for residual solvents Development of active pharmaceutical ingredients Guideline for metal impurities Safety Code Previous code Topics S1C,S1C(R) S4,S4A S5A,S5B Need for carcinogenicity studies Testing of carcinogenicity of pharmaceuticals Dose selection for carcinogenicity studies Genotoxicity: Mutation assays Genotoxicity: Standard battery of genotoxicity tests Toxicokinetics: Assessment of systemic exposure in toxicity studies Pharmacokinetics: Repeated-dose tissue distribution Single- and repeated-dose toxicity studies Reproduction studies of medicinal products Safety evaluation of biological products Safety pharmacology studies The non-clinical evaluation of QT interval prolongation potential Immunotoxicology studies Non-clinical evaluation of anticancer drugs Genotoxicity (review of guideline) Safety evaluation of biological products S10 Guidance on photosafety testing Step 1: Selection/analysis of topics to be studied. Establishment of expert working groups, and preparation of draft guidelines Step 2: Approval of draft ICH guidelines by the steering committee. Collection of opinions on draft guidelines in each country Step 3: Revision of guidelines based on the collected opinions Step 4: Establishment of ICH guidelines by the steering committee Step 5: Adoption of these guidelines in the domestic regulatory With the new codification revisions to an ICH Guideline are shown as (R1), (R2), (R3) depending on the number of revisions, revisions, and additions. The codes of Guidelines in implementation are not changed. Source: http://www.pmda.go.jp/ich/w/topics_10_6_25.pdf 2011-3 - 133 -
Step 5* E1 Step 4* E2A Code E2B(M) E2C(R1) E2D E2E E3 E4 E5(R1) E6(R1) E7 E8 E9 E10 E11 E12 E14 E15 Step 3* E2B(R3) E2F E16 Step 1* Previous code Efficacy Multidisciplinary Topics Code Previous The extent of population exposure to assess clinical safety for drugs intended for long-term treatment of non-life threatening condition Clinical safety data management: Definitions and standards for expedited reporting in the clinical phase Data elements for transmission of individual case safety reports Clinical safety data management: Periodic safety update reports Post-approval safety data management Pharmacovigilance planning (PVP) Structure and content of clinical study reports Dose-response information to support drug registration Ethnic factors in the acceptability of foreign clinical data Guidance for good clinical practice Studies in support of special populations: Geriatrics General considerations for clinical trials Statistical principles for clinical trials Choice of control group and related issues in clinical trials Clinical investigation of medicinal products in the pediatric population Principles for clinical evaluation of new antihypertensive drugs The clinical evaluation of QT interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs Definitions for genomic biomarkers, pharmacogenomics, pharmaco- genetics, genomic data, and sample coding categories Data elements for transmission of individual case safety reports Development of safety update report Genomic biomarkers related to drug response: Context, structure and format of qualification submissions Fig. 11. ICH topics and guidelines⎯Progress of harmonization 2011-3 - 134 - M1 M2 M2(e-CTD) M3(R2) M4 code M3(M) Topics Medical dictionary for regulatory activities (MedDRA) Electronic standards for transmission of regulatory information Electronic form of application Guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals Organization of the common technical document for the registration of pharmaceuticals for human use M5 Data elements and standards for drug dictionaries M6 M7 Virus and Gene Therapy Vector Shedding and Transmission Guidance on genotoxic impurities
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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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Pharmaceuticals (ICH S2B) (Notifica
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Quality Assurance Units Chapter 3 (
Page 89 and 90: y made to Notification No. 813 of t
Page 91 and 92: international harmonization of appr
Page 93 and 94: clinical exploration and developmen
Page 95 and 96: the primary objective of exploring
Page 97 and 98: dose not exceeding 1/100 of the dos
Page 99 and 100: must be analyzed precisely and obje
Page 101 and 102: (21) Structure and Content of Clini
Page 103 and 104: approved drugs and post-marketing c
Page 105 and 106: specified in the ICH guidelines (IC
Page 107 and 108: standards for the sponsoring of cli
Page 109 and 110: management of clinical trials (Arti
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
Page 121 and 122: is clear that the items relating to
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 and 136: (Table 4) Drug classification syste
Page 137 and 138: Module 2 2.3: Quality overall summa
Page 139: Step 5* Q1A(R2) Q1B Q1C Q1D Q1E Q2
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
Page 149 and 150: prepared, reported in writing and r
Page 151 and 152: etain these reports. [5] The safety
Page 153 and 154: egard to results of clinical studie
Page 155 and 156: surveyed, analytical method and oth
Page 157 and 158: marketers’ compliance surveys by
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
Page 165 and 166: Reexamination is based on submissio
Page 167 and 168: Post-marketing surveillance (PMS) s
Page 169 and 170: Planning of early post-marketing su
Page 171 and 172: (MHLW) (PMDA [KIKO]) Selection of r
Page 173 and 174: and the Role of the Regulatory Auth
Page 175 and 176: which they are entered in package i
Page 177 and 178: the beginning of the Precautions wh
Page 179 and 180: 1.5 Entries for Biological Products
Page 181 and 182: 2.2 Pharmaceutical Interview Forms
Page 183 and 184: the basis of an order issued in cas
Page 185 and 186: the journals of the Japan Medical A
Page 187 and 188: Labeling requirements of excipients
Page 189 and 190: 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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