Drug Evaluation Committee 2011-28 Inspections by Foreign Regulatory Authorities
Related classification: Other
First published: November 2011
Revised publication date: March 2021
Question
If there is an inspection by the U.S. FDA for a clinical trial conducted in Japan, is it correct to respond in the same way as for a GCP on-site inspection in Japan? Is it possible for the sponsor (pharmaceutical company) to attend inspections or meetings related to this clinical trial to the extent permitted by the regulatory authority? Also, if the regulatory authorities request inspections or access to information and materials related to this clinical trial, will the sponsor be notified?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Normally, when the U.S. FDA conducts an inspection of an investigational site overseas, the U.S. FDA will contact the U.S. applicant for drug manufacturing approval or the sponsor. Therefore, the site to be inspected will generally prepare for the inspection upon receiving a notification of the inspection from the sponsor (or CRO under contract to conduct the clinical trial). The sponsor is expected to be able to participate in the preliminary meeting between the site and the inspector. It may also be possible for the sponsor to be present on the day of the inspection or to stand by at the site.
Please refer to the following guidance for the details of the inspection.
Compliance Program Guidance Manual For FDA Staff - Chapter 48 Bioresearch Monitoring Human Drugs
- In Vivo Bioequivalence Studies (Clinical) (Program 7348.003, May 1, 2018)
- Clinical Investigators and Sponsors-Investigators (Program 7348.811, July 22, 2020)
Reason for revision of opinion
The name of the guidance and other information has been changed to reflect the revision of the U.S. FDA guidance.