Pharmaceutical Administration and Regulations in Japan - Nihs

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Phase I of clinical studies Designation of drugs ............................ 155 Phase I of clinical studies ...................... 87 General ................................................... 32 Phase II of clinical studies ......................... 87 System .................................................. 154 Phase III of clinical studies ....................... 88 Reexamination and reevaluation Phase III of clinical studies ................... 88 Information for drugs which completed PMS ........................................................... 135 reexamination or reevaluation ........ 177 SOP ....................................................... 138 Reexamination and reevaluation Post-marketing surveillance (PMS) ........... 135 Compliance review data ........................ 149 Precautions (package inserts) ................. 169 Reimbursement prices for new drugs ....... 190 Prescription drugs ...................................... 21 Research and Development Division (HPB)5 Prescription Drugs→ Approval application: Prescription Review drugs of products designated for priority Prevention of Medical Accidents ............... 51 face-to-face advice .................................. 40 Pricing formula for reimbursement price Reviews and Guidance by the PMDA revisions ................................................. 188 (KIKO) .................................................... 62 Priority Review .......................................... 39 Priority reviews .......................................... 16 S Procedures for Conduct of Clinical Studies→ Safety Division (PFSB) ............................... 4 Product Recalls ............................... → Recall safety information Product recalls (GMP) Safety information Product recalls (GMP) .......................... 114 Electronic information dissemination .... 179 Public disclosure of information on new Periodic safety reports ......................... 156 drug development Reporting system by Medical Personnel153 Public disclosure of information on new WHO safety monitoring program ....... 153 drug development ............................. 121 Safety Measures against Bovine .............. 51 Safety monitoring R During clinical studies .......................... 97 Recent revisions of NHI drug price list ...... 189 Safety studies Reevaluation Requirements ......................................... 85 General ................................................... 32 Self-inspections of manufacture (GMP) System ................................................... 158 Self-inspections of manufacture (GMP)114 Reexamination SOP for PMS ............................................ 138 Data and procedures ............................ 156 Specifications of drugs: Data for review ..................................... 105 Guidelines:Specifications of drugs: Designated classifications ..................... 158 Guidelines .............................................. 74 2011-3 - 205 -
Specified biological products ..................... 22 Stability tests of drugs Guidelines:Stability tests of drugs Guidelines ........................................... 74 Standards for Biological Materials ........... 48 Studies of drug interactions ...................... 89 Studies of drug metabolites ....................... 89 2011-3 - 206 - V Validation of manufacturing processes (GMP) Validation of manufacturing processes (GMP) ............................................... 113 W WHO safety monitoring program ........... 153
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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
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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
Page 161 and 162: Information about adverse drug reac
Page 163 and 164: 6.2 Periodic Safety Reports (Articl
Page 165 and 166: Reexamination is based on submissio
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: (MHLW) Office of New Drug III (PMDA
Page 215 and 216: (Chapter 4) Kazuyo MARUCHI Product
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Pharmaceutical Administration and Regulations in Japan - Nihs

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