Pharmaceutical Administration and Regulations in Japan - Nihs

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trial, or the director of the medical institutions involved. • When the trial is completed or discontinued, the results obtained must be compiled in a clinical trial report. When the person conducting the clinical trial learns that the study results collected from the trial concerned were not attached to the application form as application data, this fact and the reason for it must be notified in writing to the directors of the medical institutions performing the trial. • Records related to the clinical trial must be retained for the specified period. Chapter 4: Standards for conduct of clinical trials (Articles 27 to 55) Provisions to be followed by the medical institutions performing clinical trials scientifically and ethically 1) Provisions concerning the Institutional Review Boards (IRB) (Articles 27 to 34) • An Institutional Review Board (IRB), which should meet the requirements specified in Article 28, must be established by the director of the medical institution performing the trial to review and discuss the proper conduct of Pharmaceutical Regulations in Japan: clinical trials and other matters related to the trials. (However, it is not always necessary to establish an IRB in each medical institution performing the study.) • The IRB must review the ethical and scientific appropriateness of the clinical trial subject to review on the basis of the documents specified in Article 32, and state its opinion. • The person establishing the IRB must keep records of meetings and prepare a summary and retain these documents for set periods such as 3 years after completion of the clinical study. The standard operating procedures, list of members, and summary of meeting records prepared for the IRB must be made public. On the PMDA webpage (http://www.pmda.go.jp), the name of the IRB, the name of the person establishing the IRB, the address, and webpage address must be recorded to create an environment that facilitates acquisition of study-related information by clinical study collaborators and keeps a wider public informed (Notification No. 1001013 of the 2011-3 - 103 -
PFSB dated October 1, 2008 and Office Communication dated April 2, 2009). • The director of the medical institution performing the study must heed the opinions of the IRB concerning whether it is appropriate or not to perform the clinical study in the medical institution concerned. • The medical institution is not allowed to conduct a clinical trial when the opinion of the IRB is that it is not appropriate to conduct the trial. • When it is impracticable to organize an IRB for a planned trial at each institution, alternative IRB may be selected from other IRBs inside or outside the institution in the judgment of the director of medical institution. • IRB may disclose information related to IRB review to enhance the level of transparency and secure quality of its review activities. 2) Provisions related to medical institutions performing clinical trials (Articles 35 to 41) • Medical institutions performing clinical trials must have the facilities and personnel to Pharmaceutical Regulations in Japan: undertake adequate clinical observations and laboratory testing, and they must be able to take the measures required when emergencies arise among the trial subjects. • The director of the medical institution performing the trial must prepare SOP for work related to the trial, and take the necessary measures so that the clinical trial is conducted properly and smoothly in compliance with the trial protocol and the SOP. • The director of the medical institution performing the trial must cooperate with monitoring or audits by the sponsor or the person conducting the clinical trial and review by the IRB. • The director of a medical institution must appoint a person or persons to carry out trial-related clerical work. 3) Provisions related to investigators (Articles 42 to 49) • The investigator must have sufficient clinical experience to be able to conduct the trial properly. • The investigator must select the trial subjects in accordance with the objectives of the trial from the ethical and scientific standpoints. 2011-3 - 104 -
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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
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: management of clinical trials (Arti
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
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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
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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
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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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