Drug Evaluation Committee How to Cite 2004-02 GCP Ministerial Ordinance
Related classification: Other
Initial release date: June 2004
Revised release date: December 2021
Question
The sponsor is required to state as one of the items in the "Clinical Trial Protocol" that "This clinical trial will be conducted in accordance with the Declaration of Helsinki and in compliance with the ․․․․․․"Ministerial Ordinance Concerning Standards for the Conduct of Clinical Studies on Drugs (Ministry of Health and Welfare Ordinance No. 28, March 27, 1997)" as an ethical matter. The above is to be described as follows.
As for the ministerial ordinance used here, the above " " of course refers to the contents of the new GCP, and the revised GCP has been in effect since July 30, 2003.
We understand that the revised GCP includes the new GCP and adds provisions for investigator-initiated clinical trials, etc. Therefore, we believe that "Ministerial Ordinance Partially Revising Ministerial Ordinance Concerning Standards of Implementation of Clinical Trials for Pharmaceutical Products (Ministerial Ordinance No. 106 of the Ministry of Health, Labour and Welfare, 2003)" should be described in the above " ". masu。
As for the description in the "Clinical Trial Protocol" for protocols initiated after August 2003,
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1.Description of the Ministerial Ordinance for the new GCP (1997)
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2.Description of the Ministerial Ordinance for the revised GCP (2003)
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3.The ministerial ordinances for both the new GCP and the revised GCP are listed together.
(1997 and 2003)
Which of the above 1. through 3. is correct?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
When other laws, ministerial ordinances, etc. are cited in a law or ministerial ordinance, the law or ministerial ordinance number and date of enactment when it was first enacted are listed. In fact, the GCP Ministerial Ordinance cites the Pharmaceutical Affairs Law (former Pharmaceutical Affairs Law), but the law number and date of enactment of the first law are listed.
Therefore, by stating the first law/ministerial ordinance number and date of enactment, it can be interpreted as including amendments made since then.
Therefore, when describing GCP ordinances in clinical trial protocols and contracts, it is considered acceptable to state the official name of the ordinance, the date of first enactment, and the ordinance number, and when using abbreviations, to state "hereinafter abbreviated as GCP," etc. (1. is considered acceptable).
The term "new GCP" is used in the Pharmaceutical Affairs Ordinance No. 430 (March 27, 1997), but in the Pharmaceutical Affairs Ordinance No. 0612001 (June 12, 2003), the term is simply "GCP".
Reason for revision of opinion
The description of the partial revision of the GCP Ministerial Ordinance has been improved.