Pharmaceutical Administration and Regulations in Japan - Nihs

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Fig. 10 Correlation between Development Phases and Types of Study This matrix graph illustrates the relationship between the phases of development and types of study by objective that may be conducted during each clinical development of a new medicinal product. The shaded circles show the types of study most usually conducted in a certain phase of development, the open circles show certain types of study that may be conducted in that phase of development but are less usual. Each circle represents an individual study. To illustrate the development of a single study, one circle is joined by a dotted line to an inset column that depicts the elements and sequence of an individual study. 2011-3 - 131 -
Step 5* Q1A(R2) Q1B Q1C Q1D Q1E Q2 (R1) Q3A (R2) Q3B (R3) Q3C (R3) Q4B Q4B (Annex 1) Q4B (Annex 2) Q4B (Annex 3) Q5A (R1) Q5B Q5C Q5D Q5E Q6A Q6B Q7 Q8 Q9 Q10 Q4B (Annex 4a,4b,4c) Step 4* Q4B (Annex 5) Q4B (Annex 7) Q4B (Annex 8) Q4B (Annex 9) Q4B (Annex 10) Q4B (Annex 11) Q4B (Annex 12) Q8(R2) Step 3* Quality Code Previous code Topics Q2A, Q2B Q3C, Q3C(M) Q5A Q7A Q4B (Annex 6) Uniformity of dosage units Stability testing: New drug substances and products Stability testing: Photostability Stability testing: New & partially revised dosage forms Stability testing: Bracketing and matrixing Stability testing: Evaluation of stability data Validation of analytical procedures: Text and methodology Impurities in new drug substances Impurities in new drug products Impurities: Residual solvents Pharmacopoeias: Harmonized texts for use in ICH regions Test for residue on ignition Test for extractable volume of parenteral preparations Test for particulate contamination of parenteral preparations Quality of biotechnology products: Viral bioburden Quality of biotechnology products: Genetic stability Quality of biotechnology products: Stability Testing of products Quality of biotechnology products: Cell bank control (cell substrates) Quality of Biotechnology Products: Comparability of products Specifications/test methods: Chemicals/pharmacopoeial harmonization Specifications/test methods: Biological products GMP for active pharmaceutical ingredients Pharmaceutical development Quality risk management Pharmaceutical quality system Microbial limit tests Disintegration test Dissolution test Sterility test Tablet friability test Polyacrylamide gel electrophoresis Capillary electrophoresis Analytical sieving Pharmaceutical development (annex) 2011-3 - 132 -
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2011.3 INFORMATION IN ENGLISH ON JA
Page 3 and 4:
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
Page 87 and 88: 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: Module 2 2.3: Quality overall summa
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
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
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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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