Drug Evaluation Committee 2010-22 Retention Period of Medical Institution Records for Discontinuation of Development, etc.
Related classification: Record keeping
Initial release date: August 2010
Revised publication date: December 2021
Question
Please explain the retention period of records.
Is there a difference between "not attaching materials related to clinical trial results collected through a clinical trial to an application for approval" and "discontinuing the development of a study drug"? If so, what are the possible cases? Also, in the description of the retention period of records in the SOP of the site, is it interpreted that "three years have passed since the date of notification of the decision to discontinue development" is insufficient (i.e., not in accordance with the Ministerial Ordinance on GCP)?
GCP Article 41, Paragraph 2 Guidance 1(1)
The date of approval for the manufacture and marketing of the drug for which the study is being conducted (in the case of notification of discontinuation of development or notification that the clinical trial results will not be included in the application for approval pursuant to Article 24, paragraph 3 or Article 26-10, paragraph 3, the date three years have elapsed since the date of such notification)".
GCP Article 24 Clause 3 Guidance 1
"If the sponsor discontinues the development of the investigational drug (with respect to any or all of the indications, dosage and administration, or formulation), that is, if the sponsor does not attach to the application for approval the materials on the clinical trial study results collected through the clinical trial, ..."
GCP Article 34, Paragraph 1 Guidance 1
"The establisher of the investigational review committee shall keep ・・・・・ until the later of the following (1) or (2) dates. (1) The date of marketing approval of the drug for which the investigational new drug is being tested (or the date of notification of the decision to discontinue development or the decision not to attach materials related to clinical trial study results to the application pursuant to Article 24, Paragraph 3 or Article 26-10, Paragraph 3, if such notification is received)"
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
An example of "not attaching materials on clinical trial results collected through clinical trials to the application for approval" is when multiple clinical trials were conducted to apply for two indications, but the expected results were not obtained for one of the indications, and an application was filed for one of the indications, but the clinical trial results for the indication for which the application was not filed were not attached to the application. The clinical trial results for the indication for which the application was not filed are applicable.
The retention period of the records in the SOP of the site should be specified as the period stipulated in the GCP. In addition, some sponsors may request a longer retention period, so it would be desirable to stipulate the handling of such cases as well.
Reason for revision of opinion
With the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15), the provisions to be referenced have been changed. In addition, we have reorganized the content to match the current guidance.