Pharmaceutical Administration and Regulations in Japan - Nihs

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trials, must be implemented in accordance with the GPSP. The data must also be collected and prepared in accordance with these standards (post-marketing clinical trials must be conducted also in compliance with the GCP). Applications for reexamination must be completed within 3 months from the time of the designated base date. The data submitted and organization of this data should generally be as described below, with a focus on data from specified drug-use surveys and post-marketing clinical trials of the drug concerned in the application. In addition, for any other research data acquired after drug approval related to indications and/or safety of the drug concerned, a Periodic Safety Report submitted near the date of the reexamination application should be attached. (1) Summary of data for reexamination applications The data should include a summary of the drug specified in the application; specific details up to the time of reexamination application including the changes in quantity and value of product shipped and the estimated number of patients who used the drug, the status of approval and sales overseas; summary of post-marketing surveillance; information about safety and efficacy; and references. Pharmaceutical Regulations in Japan: (2) Data Attached to Reexamination Applications This data should include summary of drug use-results surveys; specified drug-use survey reports; post-marketing clinical trial reports; data from patients who have developed adverse drug reactions or infections; data from research reports; reports of specific measures adopted in Japan and overseas; and reports of serious adverse drug reactions. (3) Compliance survey data This includes data from GPSP compliance reviews as well as data from GCP and/or GLP compliance reviews as required. (4) Reference data This includes, for example, case report forms used in drug use-results surveys, package inserts at the time of reexamination application, summaries of replies, review reports, a summary of the data at the time of product approval application (for Evaluation Committees), copies of approval forms, and a copy of periodic safety report submitted closest to the reexamination application. 2011-3 - 157 -
Reexamination is based on submission of the above application data. Fig. 15 (Reexamination System) is a flow diagram of this reexamination process. After the application is received, the PMDA evaluates compliance with standards such as GPSP and conducts surveys on quality, efficacy, and safety. The application is next reviewed by the Department on Drugs of the PAFSC. Then, the MHLW issues an official report of the results of the examination. The results of these examinations are classified into one of the three approval categories shown below, and any required specific measures are adopted. Article 14 Paragraph 2 of the Pharmaceutical Affairs Law specifies three reasons for refusal of approval. These include cases where (1) the indications of the drug stated in the application have not been demonstrated; (2) the drug exhibits prominent harmful effects that outweigh any target indications, thus rendering the product not useful; and (3) the drug is judged to be markedly inappropriate with respect to public health and hygiene because of its characteristics or quality. * Designated Classifications [I] Approval refused (manufacturing and marketing suspended, approval revoked) [II] Changes in approval (modifications in approved items as directed) Pharmaceutical Regulations in Japan: [III] Approved (as per application for reexamination) 7. REEVALUATION SYSTEM (ARTICLE 14-5 OF THE PAL) The reevaluation of drugs is a system whereby the efficacy and safety of a drug, which has already been approved, is reconsidered on the basis of the current status of medical and pharmaceutical sciences. This system was initiated in December 1971 on the basis of administrative guidance. From January 1985, reevaluations were based on the Pharmaceutical Affairs Law, and the new reevaluation system came into effect from May 1988. New Reevaluation System: This new reevaluation system aimed at reevaluations of the efficacy and safety of all prescription drugs was started in May 1988. These reevaluations are at first performed by means of a review by the PAFSC. When the Council's decision requires further literature surveys by the manufacturers, they are required to perform such surveys according to the provisions of the Pharmaceutical Affairs Law (Fig 16｡ Reevaluation System). 2011-3 - 158 -
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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
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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
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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
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 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
Page 163: 6.2 Periodic Safety Reports (Articl
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
Page 189 and 190: No PMDA safety assessment team (5 t
Page 191 and 192: CHAPTER 6 Health Insurance Programs
Page 193 and 194: coverage was changed to 80% of medi
Page 195 and 196: OF DRUGS LISTED IN THE NHI DRUG PRI
Page 197 and 198: (excluding those in the JP) in the
Page 199 and 200: 0212-(6) of the Health Policy Burea
Page 201 and 202: 1998 Sept. 1997 5% 2% (Long listed
Page 203 and 204: Table 9. Requirements for Applying
Page 205 and 206: 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 .....
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(Chapter 4) Kazuyo MARUCHI Product
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