Ministerial Ordinance on Good Clinical Practice for Drugs: Pharmaceuticals and Medical Devices Agency, Japan
The following English translations of Japanese ministerial ordnances are intended to be a reference material to provide convenience for users. In the event of inconsistency between the Japanese originals and the translations, the former shall prevail. Provisional Translation (as of March 2013)∗
'Ministerial Ordinance on Good Clinical Practice for Drugs (as amended, effective December 28, 2012)', source: Pharmaceuticals and Medical Devices Agency, Japan.
Ministerial Ordinance on Good Clinical Practice for Drugs
Ordinance of the Ministry of Health and Welfare No. 28 of March 27, 1997
(As last amended by the Ordinance of Ministry of Health, Labour and Welfare No. 161 of December 28, 2012)
The Ministerial Ordinance on Good Clinical Practice (GCP) for Drugs shall be established as stated below in accordance with the following provisions of the Pharmaceutical Affairs Act (Act No. 145 of 1960): Article 14, Paragraph 3 (including cases where it shall apply mutatis mutandis in Article 14, Paragraph 6; Article 19-2, Paragraph 4; and Article 23 of the same Act),
Article 14-4, Paragraph 4, and Article 14-5, Paragraph 4 (including cases where these provisions shall apply mutatis mutandis in Article 19-4 and Article 23 of the same Act); Article 80-2, Paragraphs 1, 4 and 5; and Article 82.
Table of Contents
-
Chapter I. General Provisions (Articles 1 through 3)
-
Chapter II. Standards for Preparing Clinical Trials
-
Chapter III. Standards for Clinical Trial Management
-
Chapter IV. Standards for Conducting Clinical Trials
-
Chapter V. Standards for Documents Submitted in Reexamination etc. (Article 56)
-
Chapter VI. Standards for Sponsoring Clinical Trials etc. (Articles 57 through 59)
-
Supplementary Provisions
Disclamer: We take possible measures to ensure the accuracy of information published on this website, however, GCP Network will not assume any responsibility for any decisions/activities/actions which the user of our site performed by using any information published here.
Clinical Research News
Upcoming Clinical Research Training and Conferences
-
29 September 2023 – 02 October 2024SCDM (Society of Clinical Data Management)United States
-
10 – 11 April 2024The Society for Clinical Research Sites (SCRS)United States
-
16 – 18 April 2024InformaUnited States
-
17 – 19 April 2024SCDM (Society of Clinical Data Management)Poland
-
21 – 23 May 2024InformaBelgium
-
03 – 04 June 2024The Society for Clinical Research Sites (SCRS)United States
-
16 – 17 July 2024The Society for Clinical Research Sites (SCRS)Australia
-
27 September – 29 October 2024The Society for Clinical Research Sites (SCRS)United States
即将进行的临床试验
-
Universidad Complutense de MadridOsteology Foundation招聘中
-
Sidney Kimmel Comprehensive Cancer Center at Johns...National Institutes of Health (NIH)尚未招聘
-
McGill University Health Centre/Research Institute...尚未招聘健康受试者 | 1 型糖尿病 (T1D)
-
North Jersey AIDS Alliance dba North Jersey Community...City University of New York, School of Public Health尚未招聘艾滋病毒感染 | 过量 | 丙型肝炎病毒