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

 

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