- Page 1 and 2: 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 ····
- Page 7 and 8: 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: contribution to drug research and d
- 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 and 62: Patent right 1 Patent right 2 Calcu
- Page 63 and 64: Foreign manufacturer with manufactu
- Page 65 and 66: Table. 1 List of Main Controlled Su
- Page 67 and 68: 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 (
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y made to Notification No. 813 of t
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international harmonization of appr
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clinical exploration and developmen
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the primary objective of exploring
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dose not exceeding 1/100 of the dos
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must be analyzed precisely and obje
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(21) Structure and Content of Clini
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approved drugs and post-marketing c
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specified in the ICH guidelines (IC
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standards for the sponsoring of cli
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management of clinical trials (Arti
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PFSB dated October 1, 2008 and Offi
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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
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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