Pharmaceutical Administration and Regulations in Japan - Nihs

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Committee on Safety of Chemical Substances Committee on Veterinary Drugs ・ Subcommittee on Chemical Substances ・ Subcommittee on PRTR substances ・ Subcommittee on safety measures for household products ・ Subcommittee on Veterinary Biological Products ・ Subcommittee on Veterinary Antibiotics ・ Subcommittee on Veterinary Non-proprietary drugs ・ Subcommittee on Reexamination of Veterinary Drugs ・ Subcommittee on Residues in Veterinary Drugs ・ Subcommittee on Fishery Drugs Fig. 3 Organization of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC) (17 Committees and 18 Subcommittees, November 12, 2010) 2011-3 - 15 -
CHAPTER 2 Pharmaceutical Laws and Regulations 1. PHARMACEUTICAL LAWS Pharmaceutical administration in Japan is based on various laws and regulations, consisting mainly of: (1) the Pharmaceutical Affairs Law, (2) Pharmacists Law, (3) Law Concerning the Establishment for Pharmaceuticals and Medical Devices Organization, (4) Law Concerning Securing Stable Supply of Blood Products, (5) Poisonous and Deleterious Substances Control Law, (6) Narcotics and Psychotropics Control Law, (7) Cannabis Control Law, (8) Opium Law, and (9) Stimulants Control Law. For the enforcement and management of these laws, detailed regulations are prepared by the government in the form of ministerial ordinances and notices, such as the Enforcement Ordinance and the Enforcement Regulations of the Pharmaceutical Affairs Law, and notifications issued by the Director General of the Bureaus or the directors of the Divisions in charge in the Ministry of Health, Labour, and Welfare. Pharmaceutical Regulations in Japan: 2. PHARMACEUTICAL AFFAIRS LAW The objective of the Pharmaceutical Affairs Law is to improve public health through regulations required to assure the quality, efficacy, and safety of drugs, quasi-drugs, cosmetics, and medical devices, and through measures to promote R&D of drugs and medical devices that are especially essential for health care. Modern pharmaceutical legislation originated in Japan with the enactment of the Regulations on Handling and Sales of Medicines in 1889. The Pharmaceutical Affairs Law was enacted in 1943 and has been revised several times since then. The current Pharmaceutical Affairs Law (Law No. 145) is the result of complete revisions in 1948 and 1960. Subsequent revisions have included those related to the reexamination of new drugs, the reevaluation of drugs, notification of clinical study protocols, and items required for sponsoring clinical studies in 1979, those related to direct manufacturing approval applications by overseas pharmaceutical manufacturers, and the transfer of manufacturing or import approvals in 1983, and those related to promotion of R&D of orphan drugs and priority reviews for such drugs in 1993. In 2002, the Pharmaceutical Affairs Law (Law No. 96, July 31, 2002) was revised 2011-3 - 16 -
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: Committee on Japanese Pharmacopoeia
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
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 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
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 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 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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Pharmaceutical Administration and Regulations in Japan - Nihs

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