Drug Evaluation Committee 2009-35 Procedures for Requesting a Clinical Trial by an In-Country Manager for a Clinical Trial (Part 2)
Related classification: Other
First published: Jan 2010
Revised: Mar. 2021
Question
Article 15 of the GCP stipulates that "A person who intends to request a clinical trial and does not have a domicile in Japan shall appoint a person who can request the clinical trial on behalf of the person who intends to request the clinical trial, in order to have the person take measures necessary to prevent the occurrence or spread of health hazards due to the investigational drug. (2) A person who has a domicile in Japan (including a representative of a foreign corporation having an office in Japan) shall be appointed from among persons who have a domicile in Japan and who can request a clinical trial on behalf of the person who intends to request the clinical trial. (2) The Company shall appoint a person from among persons having a domicile in Japan (including a representative of a foreign corporation having an office in Japan) who can request a clinical trial on behalf of the person who is to request the clinical trial. The "domestic administrator of a clinical trial" shall be appointed from among persons who have an address in Japan (including a representative of a foreign corporation having an office in Japan) and shall have this person (hereinafter referred to as the "domestic administrator of a clinical trial") perform the procedures for requesting a clinical trial. (2) The "National Administrator of Clinical Trials" is stated as follows. When a person acting on behalf of the sponsor (e.g., a CRO) performs this task, "the CRO shall have the person perform the procedures for the request for the clinical trial. However, it seems to me that it is not clear exactly what kind of work must be performed. We would appreciate your clarification on this point.
Also, who is ultimately responsible for the clinical trial?
JPMA's Opinion
Regarding the request for a clinical trial in Japan by a foreign manufacturer, please refer to "3. Request for a Clinical Trial in Japan by a Foreign Manufacturer" and "3. Please refer to "7. Matters Concerning Clinical Trials" in "Partial Revision of the Pharmaceutical Affairs Act, etc., Pursuant to the Act for Partial Revision of Relevant Acts for Facilitating the Acquisition of Model Approval, etc. by Foreign Manufacturers (Enforcement Notice)" (August 1, 1983, Yakuhatsu No. 596), etc. As stated in the section 7-2 of the NDA No. 596, the domestic manager of the clinical trial is responsible for all procedures with regulatory authorities and medical institutions on behalf of the sponsor, but the sponsor has the ultimate responsibility for the clinical trial.
Reason for revision
We have made minor changes to the descriptions in accordance with the issuance of GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).