Drug Evaluation Committee 2011-27 Overseas Regulations Applicable to Japanese Medical Institutions Conducting Multinational Clinical Trials
Related classification: Other
First published: November 2011
Revised publication date: March 2021
Question
Are there any other relevant regulations to be complied with in addition to the Pharmaceutical Affairs Law, GCP, and ICH-GCP when conducting an international clinical trial in Japan? Are there any other relevant laws and regulations that must be complied with when conducting an international clinical trial in Japan in addition to the Pharmaceutical Affairs Law, GCP, and ICH-GCP? Are laws and regulations related to the prevention of bribery required at the time of the conclusion of the contract for this clinical trial?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The applicable foreign regulations differ depending on the country in which the clinical trial is conducted and the country in which the application for drug manufacturing approval is planned to be filed using the clinical trial. For example, a Financial Dosclosure Form is required for a clinical trial that will be used for an application in the U.S., and a Form 1572 is usually required for a US IND Study. It is recommended that you consult with the sponsor of each clinical trial regarding applicable overseas regulations, including anti-bribery laws and regulations, and the details to be included in the contract.
Reason for revision of opinion
In accordance with the enforcement of the Pharmaceutical Affairs Law (November 25, 2014), we have made minor improvements to the questions.