Pharmaceutical Administration and Regulations in Japan - Nihs

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of New Drug III, Office of New Drug IV, Office of New Drug V, Office of Biologics I, Office of Biologics II, Office of OTC and Generic Drugs, Office of Medical Devices I, Office of Medical Devices II, Office of Conformity Audit, Office of Safety I, Office of Safety II, Office of Compliance and Standards Officer, [Fig. 2 Organization of the Pharmaceutical and Food Safety Bureau (PFSB) and the Pharmaceuticals and Medical Devices Agency (PMDA)]. The duties are indicated below. The Second Medium Range Plan (2009 – 2014) is now underway and efforts are being made to shorten the review period, make reviews more efficient, promote international harmonization by strengthening ties with Western and Asian countries, and participation in global clinical trials. 1) Drug ADR Relief Work • Provision of medical benefits to cover healthcare expenses, disability pensions, and survivor’s pensions for individuals suffering disease or disability due to adverse drug reactions or bioderived infections • Provision of medical allowances for treatment of myelo-optico-neuropathy (SMON) patients and for HIV carriers and AIDS patients • Surveys on damage caused by drugs and research on treatment, etc. of adverse drug reactions as health and welfare work • Provision of medical allowances based on the Special Measures Law for Provision of Medical Allowances for Treatment of Hepatitis C Patients Infected by Specified Fibrinogen Concentrates or Specified Pharmaceutical Regulations in Japan: Coagulation Factor XI Concentrates. 2) Review Related Work • Approval reviews of new drugs and medical devices based on the Pharmaceutical Affairs Law (PAL) • Guidance and advice related to clinical trials • Reviews of GLP and GCP compliance of attached data of approval applications and reexamination and reevaluation applications • Reviews of manufacturing facilities, processes, and quality control by GMP inspections • Confirmation of reexaminations and reevaluations based on the Pharmaceutical Affairs Law 3) Safety Measures • Collection, analysis, and dissemination of information related to the quality, efficacy, and safety of drugs and medical devices • Consultations with consumers and other parties concerning drugs and medical devices • Guidance and advice for manufacturers, etc. to improve the safety of drugs and medical devices The work of the review and safety offices is detailed below. 4.1 Office of New Drug I This office confirms clinical trial notifications and adverse drug reactions and conducts reviews required for approval, reexaminations, and 2011-3 - 7 -
eevaluation of gastrointestinal drugs, dermatologic drugs, hormone preparations, and metabolic disease drugs (e.g., anti-diabetic, osteoporosis, gout, and congenital metabolic disorder drugs) 4.2 Office of New Drug II This office confirms clinical trial notifications and adverse drug reactions and conducts reviews required for approval, reexaminations and reevaluation of new cardiovascular drugs, drugs to treat Parkinson’s disease, drugs to improve cerebral circulation and metabolism, drugs to treat Alzheimer’s disease, urogenital and anal drugs, combination drugs, radiopharmaceuticals, and contrast media. 4.3 Office of New Drug III This office confirms clinical trial notifications and adverse drug reactions and conducts reviews required for approval, reexaminations, and reevaluation of new central nervous system drugs, peripheral nervous system drugs, anesthetic agents, sensory organ drugs (other than drugs for inflammatory diseases), and narcotics. 4.4 Office of New Drug IV This office confirms clinical trial notifications and adverse drug reactions and conducts reviews required for approval, reexaminations, and reevaluation of antibacterial drugs, antiparasitic agents, antiviral agents (except for anti-HIV/AIDS agents), new respiratory tract drugs, anti-allergy drugs sensory organ drugs (limited to drugs for Pharmaceutical Regulations in Japan: inflammatory diseases), and anti-HIV/AIDS agents. 4.5 Office of New Drug V This office confirms clinical trial notifications and adverse drug reactions and conducts reviews required for approval, reexaminations, and reevaluations of antineoplastic drugs. 4.6 Office of Biologics I In the Office of Biologics, the PMDA confirms clinical trial notifications and adverse drug reactions and conducts reviews required for approval, reexaminations, and reevaluation of globulins, blood coagulation factor products, etc. This office also undertakes preliminary reviews for applications for verification of drugs for gene therapy and medical devices using cells and tissues, preliminary reviews for applications for approval or verification based on the Cartagena Protocol, and quality review of antibody preparations. 4.7 Office of Biologics II This office confirms clinical trial notifications and adverse drug reactions of vaccines, antidotes, and drugs for cell therapy and performs the reviews required for approval, reexamination, or reevaluation. The office also performs preliminary reviews for approval applications of drugs and medical devices using cells and tissues. 2011-3 - 8 -
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: health care information-processing
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 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
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http://www.pmda.go.jp/topics/file/
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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 (
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y made to Notification No. 813 of t
Page 91 and 92:
international harmonization of appr
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clinical exploration and developmen
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the primary objective of exploring
Page 97 and 98:
dose not exceeding 1/100 of the dos
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must be analyzed precisely and obje
Page 101 and 102:
(21) Structure and Content of Clini
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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
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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
Page 175 and 176:
which they are entered in package i
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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
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the basis of an order issued in cas
Page 185 and 186:
the journals of the Japan Medical A
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Labeling requirements of excipients
Page 189 and 190:
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
Page 195 and 196:
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
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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