Chapter I. General Provisions

(Articles 1 through 3): Ministerial Ordinance on Good Clinical Practice for Drugs, PMDA Japan

Article 1. Objectives

This Ministerial Ordinance is intended to provide the standards, which serve as the GCP for Drugs, specified by the Minister of Health, Labour and Welfare pursuant to Article 14, Paragraph 3 of the Pharmaceutical Affairs Act (hereinafter referred to as "PAA") (including cases where it shall apply mutatis mutandis in Paragraph 9 of the same article; and Article 19-2, Paragraph 5 of PAA; the same shall apply hereinafter) and Article 14-4, Paragraph 4; and Article 14-6, Paragraph 4 of PAA (including cases where these provisions shall apply mutatis mutandis in Article 19-4 of PAA; the same shall apply hereinafter), and the standards specified by MHLW Ordinance pursuant to Articles 80-2, Paragraphs 1, 4 and 5 of PAA so as to ensure the scientific quality of clinical trials and the reliability of clinical trial data while the rights, safety and welfare of human subjects are protected and promoted.

Article 2. Definitions

1. The term "post-marketing clinical study" as used in this Ministerial Ordinance means post-marketing clinical studies specified in Article 2, Paragraph 4 of Good Post-marketing Study Practice (GPSP) for Drugs (MHLW Ordinance No. 171 of 2004).

2. The term "medical institution" as used in this Ministerial Ordinance means medical sites where a clinical trial or post-marketing clinical study is conducted.

3. The term "investigator" as used in this Ministerial Ordinance means a physician or dentist who supervises activities related to a clinical trial conducted at a medical institution.

4. The term "post-marketing clinical study investigator" as used in this Ministerial Ordinance means a physician or dentist who supervises activities related to a post-marketing clinical study conducted at the medical institution.

5. The term "test drug" as used in this Ministerial Ordinance means a drug that is tested in a clinical trial or a drug product that is tested in a post-marketing clinical study.

6. The term "comparator" as used in this Ministerial Ordinance means a drug or other substances, used as a reference in a clinical trial or a post-marketing clinical study for the purpose of comparison with a test drug.

7. The term "investigational products" as used in this Ministerial Ordinance means a test drug and a comparator (limited to the drugs that are used for the clinical trial).

8. The term "post-marketing clinical study drug" as used in this Ministerial Ordinance means a test drug and a comparator (limited to the drug products that are used for the post-marketing clinical study).

9. The term "subject/trial subject" as used in this Ministerial Ordinance means an individual who receives an investigational product or a post-marketing clinical study drug, or an individual who participates in the clinical trial as a control.

10. The term "source documents" as used in this Ministerial Ordinance means data and other records obtained by the administration of investigational products or post-marketing clinical study drug to subjects and the medical treatment of the subjects in the clinical trial.

11. The term "subinvestigator" as used in this Ministerial Ordinance means a physician or a dentist who takes charge of part of the activities related to a clinical trial under the supervision of the investigator at a medical institution.

12. The term "post-marketing clinical study subinvestigator" as used in this Ministerial Ordinance means a physician or a dentist who takes charge of part of the activities related to a post-marketing clinical study under the supervision of the post-marketing clinical study investigator at a medical institution.

13. The term "case report form (CRF)" as used in this Ministerial Ordinance means a document containing source data on each trial subject and evaluation of those data by the investigator or subinvestigator, or by the post-marketing clinical study investigator or post-marketing clinical study subinvestigator.

14. The term "clinical research coordinators" as used in this Ministerial Ordinance means pharmacists, nurses, or other healthcare professionals who collaborate in activities related to a clinical trial under the supervision of either the investigator or the subinvestigator at a medical institution.

15. The term "post-marketing clinical research coordinators" as used in this Ministerial Ordinance means pharmacists, nurses, or other healthcare professionals who collaborate in activities related to a post-marketing clinical study under the supervision of either the post-marketing clinical study investigator or the post-marketing clinical study subinvestigator at a medical institution.

16. The term "coordinating investigator" as used in this Ministerial Ordinance means a physician or dentist to whom the duties of coordinating clinical trial-related issues, including interpretation of the protocol at the relevant medical institutions, (hereinafter referred to as the “duties of coordination”) are assigned by the sponsor (which refers to the one specified in Article 2, Paragraph 18 (the same shall apply in the next paragraph) or sponsor-investigator if the clinical trial is conducted according to a single protocol but at more than one medical institution.

17. The term "coordinating committee" as used in this Ministerial Ordinance means a committee (composed of multiple physicians or dentists) to which the duties of coordination are assigned by the sponsor or sponsor-investigator if the clinical trial is conducted according to a single protocol but at more than one medical institution.

18. The term "monitoring" as used in this Ministerial Ordinance means the act of overseeing the progress of a clinical trial or post-marketing clinical study, and of determining whether the clinical trial or post-marketing clinical study is being conducted in compliance with this Ministerial Ordinance and the protocol of the clinical trial (hereinafter referred to as "protocol") or the protocol of the post-marketing clinical study (hereinafter referred to as "post-marketing protocol"), in order to ensure that the clinical trial or post-marketing clinical study is properly conducted. Such act is performed at the medical institutions by a person sponsoring a clinical trial (hereinafter referred to as "sponsor") or a person sponsoring a post-marketing clinical study (hereinafter referred to as "post-marketing clinical study sponsor"), or by an individual appointed by a sponsor-investigator.

19. The term "audit" as used in this Ministerial Ordinance means an examination of trial-related activities to determine whether the clinical trial or post-marketing clinical study has been conducted in compliance with this Ministerial Ordinance and the protocol or the post-marketing protocol, in order to assure the reliability of data collected in the clinical trial or post-marketing clinical study. Such examination is performed by a sponsor or a post-marketing clinical study sponsor, or by an individual appointed by a sponsor-investigator.

20. The term "adverse event" as used in this Ministerial Ordinance means any disease or its clinical signs occurring in a subject who has been treated with an investigational product or post-marketing clinical study drug.

21. The term "legally acceptable representative" as used in this Ministerial Ordinance means an individual who exercises parental rights over a subject, the subject’s spouse or guardian, or any other person who is considered to be such a representative.

22. The term "person who intends to be a sponsor-investigator" as used in this Ministerial Ordinance means a physician or dentist as a prospective investigator who intends to submit a clinical trial notification pursuant to Article 80-2, Paragraph 2 of PAA in order to conduct a clinical trial at the medical institution etc. to which the physician or dentist belongs (including a physician or dentist as a prospective coordinating investigator who intends to submit a clinical trial notification pursuant to Article 80-2, Paragraph 2 of
PAA, on behalf of all participating investigators, for a clinical trial conducted according to a single protocol but at more than one medical institution).

23. The term "sponsor-investigator" as used in this Ministerial Ordinance means an investigator who has submitted a clinical trial notification pursuant to Article 80-2, Paragraph 2 of PAA in order to conduct a clinical trial at the medical institution etc. to which the sponsor-investigator belongs (including a coordinating investigator who has submitted a clinical trial notification pursuant to Article 80-2, Paragraph 2 of PAA, on behalf of all participating investigators, for a clinical trial conducted according to a single protocol but at more than one medical institution).

24. The term "investigational product provider" as used in this Ministerial Ordinance means an individual who provides investigational products to a sponsor-investigator.

Article 3. Standards for Documents Submitted in Product Application

1. With regard to the documents as stipulated in Article 14, Paragraph 3 of PAA concerning a drug clinical trial conducted by a person who intends to obtain approval as stipulated in Article 14 or Article 19-2 of PAA, the relevant data shall be collected and generated in compliance with the provisions of Chapter II, Section 1; Chapter III, Section 1; and Chapter IV (excluding Article 29, Paragraph 1, Item (2); Article 31, Paragraph 4; Article 32, Paragraphs 4 and 7; Article 33, Paragraph 3; and Article 48, Paragraph 3).

2. With regard to the documents as stipulated in Article 14, Paragraph 3 of PAA concerning a drug clinical trial conducted by a sponsor-investigator, the relevant data shall be collected and generated in compliance with the provisions of Chapter II, Section 2; Chapter III, Section 2; and Chapter IV (excluding Article 29, Paragraph 1, Item (1); Article 32, Paragraphs 6 and 8; and Article 48, Paragraph 2).

Ministerial Ordinance on Good Clinical Practice for Drugs:  Pharmaceuticals and Medical Devices Agency, Japan

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