Pharmaceutical Administration and Regulations in Japan - Nihs

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Applicant P M D A Meeting Applicant + Manufacturing sites Review Inspection Inquiries and confirmation from PMDA Presentations and replies from applicant Interview Fig. 5 Flowchart of Approval Review GMP inspection Team review Reliability review Review report (1) Outside experts Review Review experts + Outside experts Summary on main issues * Discussion on main issues, coordination of opinions (*Paper discussions also held) i ti Applicant Review * Meeting for explanation (presentation) by applicant + * Discussion on main issues Applicant’s Outside experts GMP review results (notification: results) Approval experts * Meeting presided over by person in charge of review (or general review supervisor) * Meeting may be held twice. Review expert Review experts + Outside experts To be held following face-to-face meeting Review report (1) Review results (Notification of results) M H L W Designation / consultation Advice Inquiries Replies Pharmaceutical Affairs and Food Sanitation Council 2011-3 - 55 -
Foreign manufacturer with manufacturing approval (1) Manufacturing/marketing approval application M H L W (2) Restrictive approval of drugs manufactured overseas (1) Designation of manufacturer/marketer (3) Manufacturing/marketing order Designated manufacturer/marketer in Japan (4) Manufacture and marketing Fig. 6 Procedure for manufacturing and marketing of drugs for overseas manufacturers in Japan 2011-3 - 56 -
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2011.3 INFORMATION IN ENGLISH ON JA
Page 3 and 4:
Table of Contents CHAPTER 1 ···
Page 5 and 6:
4.1 GMP Compliance Reviews ····
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TABLE 3 DATA TO BE SUBMITTED WITH A
Page 9 and 10:
eliability of application data. Fol
Page 11 and 12: 3) Control of household products co
Page 13 and 14: health care information-processing
Page 15 and 16: eevaluation of gastrointestinal dru
Page 17 and 18: contribution to drug research and d
Page 19 and 20: Ministry of Health, Labour, and Wel
Page 21 and 22: Committee on Japanese Pharmacopoeia
Page 23 and 24: CHAPTER 2 Pharmaceutical Laws and R
Page 25 and 26: 11) (License standards, restriction
Page 27 and 28: of approvals and licenses, approval
Page 29 and 30: 2) Classification according to hand
Page 31 and 32: (3) Quasi-drug marketing business l
Page 33 and 34: manufacturer submits an MF registra
Page 35 and 36: (4) On-site surveys for accreditati
Page 37 and 38: y testing facilities for nonclinica
Page 39 and 40: Implementation of Clinical Studies
Page 41 and 42: December 21, 2005. Based on this La
Page 43 and 44: Activities Encouraging Illicit Cond
Page 45 and 46: (7) General review conference (main
Page 47 and 48: diseases, a decision must be made w
Page 49 and 50: and use of drugs for pediatric use
Page 51 and 52: codevelopment group and requirement
Page 53 and 54: January 28, 2011 entitled “Issuan
Page 55 and 56: pharmaceutical excipients, physicoc
Page 57 and 58: application review of raw materials
Page 59 and 60: half of the 1980s and there were al
Page 61: Patent right 1 Patent right 2 Calcu
Page 65 and 66: Table. 1 List of Main Controlled Su
Page 67 and 68: Table. 2 Divisions of the Pharmaceu
Page 69 and 70: acceptance of the data is condition
Page 71 and 72: p) Consultations on compliance with
Page 73 and 74: http://www.pmda.go.jp/topics/file/
Page 75 and 76: Approval of Manufacturing/Marketing
Page 77 and 78: Summary of biopharmaceutics and ass
Page 79 and 80: 1998 and partial revision by Office
Page 81 and 82: evised or established concerning ph
Page 83 and 84: are performed on the basis of the G
Page 85 and 86: 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
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e judged by personnel of the qualit
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standards, the Minister of Health,
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esults thereof. * Manufacturer, etc
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is clear that the items relating to
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carries out the duties set forth be
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in the two countries. These mutual
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PMSB dated February 22, 2000), Guid
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Information on approval reviews for
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Nonclinical studies Clinical studie
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(Table 3) Drug classification syste
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(Table 4) Drug classification syste
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Module 2 2.3: Quality overall summa
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Step 5* Q1A(R2) Q1B Q1C Q1D Q1E Q2
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Step 5* E1 Step 4* E2A Code E2B(M)
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1998. Furthermore, a new guideline,
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supervisor, quality assurance super
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work is required and retention of c
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prepared, reported in writing and r
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etain these reports. [5] The safety
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egard to results of clinical studie
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surveyed, analytical method and oth
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marketers’ compliance surveys by
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approval (known or unknown). g) Ser
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Information about adverse drug reac
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6.2 Periodic Safety Reports (Articl
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Reexamination is based on submissio
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Post-marketing surveillance (PMS) s
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Planning of early post-marketing su
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(MHLW) (PMDA [KIKO]) Selection of r
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and the Role of the Regulatory Auth
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which they are entered in package i
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the beginning of the Precautions wh
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1.5 Entries for Biological Products
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2.2 Pharmaceutical Interview Forms
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the basis of an order issued in cas
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the journals of the Japan Medical A
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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
Page 203 and 204:
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) ......
Page 209 and 210:
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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