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

  • Section 1. Standards for Preparing Clinical Trials by Persons  Who Intend to Sponsor Clinical Trials (Articles 4 through 15)

  • Section 2. Standards for Preparing Clinical Trials by Persons  Who Intend to be a Sponsor-investigator (Articles 15-2 through 15-9)

• Chapter III. Standards for Clinical Trial Management

  • Section 1. Standards for Clinical Trial Management by Sponsor (Articles 16 through 26)

  • Section 2. Standards for Clinical Trial Management by Sponsor-investigator (Articles 26-2 through 26-12)

• Chapter IV. Standards for Conducting Clinical Trials

  • Section 1. Institutional Review Board (Articles 27 through 34)

  • Section 2. Medical Institution (Articles 35 through 41)

  • Section 3. Investigator (Articles 42 through 49)

  • Section 4. Informed Consent of Subjects (Articles 50 through 55)

• 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

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