Pharmaceutical Administration and Regulations in Japan - Nihs

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application. - The marketer, etc. who acts as the agent for the application files the application after confirming from the applicant the type of corporation of the applicant, name, address, and agent. The contact information for the agent, and whether the agent is a marketing authorization holder or a manufacturer is entered in the Remarks section of the application form. (2) Timing of applications for accreditation of overseas manufacturers The application should be submitted by the time of the marketing approval application. When accreditation is not obtained beforehand, “under application” should be entered in the marketing approval application form (Marketing approval can not be obtained without accreditation approval). (3) Outline of the structure and facilities of the manufacturing plant required for accreditation of overseas manufacturers and attached documentation - The outline of the structure and facilities of the manufacturing plant should be based on that in the manufacturing business license application in Japan. A list of the Pharmaceutical Regulations in Japan: structures and facilities must be included. - When Japanese can not be used as the language in the attached documentation under special circumstances, a foreign language can be used, but a Japanese translation must be attached in such cases. If the foreign language is not English, certification of the translator must be attached. - A medical certificate from a physician must be submitted when the applicant is a corporation of the executives involved in the business, namely the executive with representative authority and executives involved in the business without representative authority, and a table showing the duties of the executives must be attached. When it is difficult to submit medical certificates for physicians for unavoidable reasons in countries where the overseas manufacturer has received authorization, it is possible to submit documents verifying that the executives involved do not correspond to the provisions of Article 5, Item 3(d) (excluding the part related to adult wards) and (e) in place of the medical certificates for physicians. 2011-3 - 27 -
(4) On-site surveys for accreditation of overseas manufacturers When a GMP compliance survey is performed simultaneously with the accreditation, the structures and facilities are required for accreditation to be confirmed in the GMP compliance survey, as a rule. 3.8 Drug Retail Seller Licensing A license must be obtained from the Prefectural Governor or other specified officials for marketing or otherwise providing of drugs. Licenses for drug retailers have been classified as follows based on amendment of the Pharmaceutical Affairs Law enacted on June 14, 2006 (Law No. 69: enforced from June 1, 2009). : (1) Pharmacies (2) Store-based drug sellers (3) Drug sellers by household distribution (4) Drug sellers by wholesale distribution * For store-based drug sellers and drug sellers by household distribution, qualifications (prefectural examination) for newly registered sellers have been established in addition to the those for pharmacists. These sellers can market drugs except for type 1 drugs. Pharmaceutical Regulations in Japan: 3.9 Quality Standards and Government Certification The Japanese Pharmacopoeia, Japanese Pharmaceutical Codex, Japanese Pharmaceutical Excipients, and other similar standards have been specified as quality standards. Certain specified drugs such as biological products must not be marketed or supplied without government certification based on batch tests. 3.10 Labeling and Package Inserts Specified items must be entered on the immediate container of drugs. The package inserts must contain indications, dosage/administration, precautions, and precautions for handling. All ingredients used as excipients must be included in the package inserts of prescription and non-prescription drugs. Entries in the package inserts of biological products are specified in Notification No. 0515005 of the PFSB dated May 15, 2003 and labeling on the immediate container or packaging of biological products is specified in Notification No. 0515017 of the PFSB dated May 15, 2003. These specifications came into effect from July 30, 2003. According to the Pharmaceutical Affairs Law amended on April 1, 2005, a new regulatory category for prescription drug labeling 2011-3 - 28 -
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 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: manufacturer submits an MF registra
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
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
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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
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(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
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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
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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
Page 123 and 124:
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
Page 129 and 130:
Information on approval reviews for
Page 131 and 132:
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
Page 191 and 192:
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
Page 207 and 208:
Index 1 15-Day reports (ADR) ......
Page 209 and 210:
Quality Standards and Government Ce
Page 211 and 212:
(MHLW) Office of New Drug III (PMDA
Page 213 and 214:
Specified biological products .....
Page 215 and 216:
(Chapter 4) Kazuyo MARUCHI Product
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