Drug Evaluation Committee 2007-35 Necessity of stating in the clinical trial agreement that the sponsor will be present at the GCP site visit
Related classification: clinical trial contracting procedures
First published: August 2008
Revised: April 2013
Question
Is it acceptable for the sponsor to be present during regulatory investigations?
Background of the question
Recently, when signing a new clinical trial agreement with a foreign company, we received an offer to include a clause in the agreement stating that "the site shall permit the presence of the sponsor at any inspections or meetings related to this clinical trial by the regulatory authorities.
In fact, is the presence of the sponsor permitted when an on-site inspection is conducted at the medical institution? Also, do we have to accept this kind of agreement?
The term "regulatory inspections" includes both domestic and international inspections.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The notice issued by the Pharmaceuticals and Medical Devices Agency (PMDA) regarding GCP inspections of drug application materials does not mention whether or not the sponsor can be present during the inspection at the site of the medical institution.
On the other hand, there is a possibility that overseas regulatory authorities may investigate Japanese medical institutions when applying for approval overseas. Many overseas regulatory authorities, including the U.S. FDA, allow the sponsor to be present during investigations at the site. Considering the differences in language and regulatory requirements in each country, the presence of a sponsor who understands these differences may be desirable to facilitate the investigation.
In any case, the presence of the sponsor is not possible without the consent of both the regulatory authority on the side of the investigation and the accepting medical institution. Therefore, if you include such a clause in the contract, we request that you limit the clause to "only when the regulatory authority permits" or, even if you do not include such a clause, please cooperate in the presence of the sponsor when the regulatory authority conducting the investigation permits it.
Reason for revision of opinion
Since this notice is frequently revised, we have omitted the notice number and other information.