Pharmaceutical Administration and Regulations in Japan - Nihs

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The necessary measures so that appropriate treatment can be given to subjects when adverse events occur must be taken beforehand. • The investigator must prepare the proper case report forms as specified in the protocol, etc. and sign or seal them. • When deaths suspected of being caused by adverse reactions of the investigational product or other serious adverse events occur, the investigator must immediately report this to the director of the medical institution performing the trial and inform the sponsor or the person supplied with the investigational product when the trial is investigator-initiated. 4) Provisions concerning informed consent of subjects (Articles 50 to 55) • When a prospective subject is asked to participate in a clinical trial, the investigator must appropriately explain the contents of the clinical trial and other matters beforehand to the subject using "written information" containing required items, and obtain the written consent of the Pharmaceutical Regulations in Japan: subject. • The investigator making the explanation and the prospective subject must date and sign or seal the consent form to make the consent effective. Chapter 5: Standards concerning reexamination data (Article 56) GCP standards also apply to the collection and preparation of data concerning the results of post-marketing clinical trials to be submitted for reexaminations or reevaluations, but taking account of the nature of post-marketing clinical trials, certain provisions for clinical trials for new drug application are applied to those for reexamination and the required changes in reading shall be made accordingly in this article. Chapter 6: Standards concerning sponsoring of clinical trials (Article 57 to 59) These GCP standards also contain provisions concerning the acts of prospective sponsors of clinical trials or persons conducting the clinical trials (Article 57), institutions requested to perform clinical trials (Article 58) and clinical 2011-3 - 105 -
trial sponsors (Article 59). However, since the scope of application differs from that of the standards related to approval review data, certain provisions for clinical trials for new drug application are applied for those for reexamination and the required changes in reading shall be made accordingly in this article. Clinical trials performed to obtain data for approval applications must be conducted, results collected and data prepared in accordance with the GCP. In addition to clinical trials sponsored by companies, it is also possible for investigator-initiated clinical trials to be performed for the preparation of approval application data in compliance with the GCP. With the legalization of the GCP standards, data from clinical trials subject to the GCP will not be accepted as approval application data unless the trial was conducted and the data collected and prepared in accordance with the GCP. Application data from clinical trials submitted to the MHLW must first undergo a GCP compliance review to assure that it meets GCP standards. This review consists of a paper inspection and on-site inspection at the medical institution(s) performing the trial, etc. The review is intended to confirm the Pharmaceutical Regulations in Japan: reliability of the data as application data. These GCP compliance reviews are performed by the PMDA at the request of the MHLW for data collected and prepared in Japan. The approval review is then undertaken by the MHLW in accordance with the results of PMDA review. The on-site inspections are performed at both the sponsor's facilities and the medical institution(s) performing the trial. Inspections of the sponsor's facilities examine the organization, structure and management of the GCP-related division, GCP compliance of clinical trials and confirmation of the items included in the trial results. Inspections in the medical institutions review the outline of the facilities and organization, the structure and operation of the IRB, GCP compliance of the clinical trial, and items in the case report forms. 9) Investigational Product GMP In Article 17, Supply of the Investigational Product, in the GCP ordinance, it specifies that the sponsor shall supply to the medical institution performing the study investigational product manufactured in factories applying appropriate manufacturing control and quality control methods and with the buildings and facilities required to 2011-3 - 106 -
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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
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
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: PFSB dated October 1, 2008 and Offi
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 and 140: Step 5* Q1A(R2) Q1B Q1C Q1D Q1E Q2
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
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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
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