December 27, 2000
Mr. Jun'ichi Shiraishi
Inspection and Guidance Division
Pharmaceutical and Medical Safety Bureau
Ministry of Health and Welfare
Subject: Exchange of Certain Information on Pharmaceutical Products
Dear Mr. Shiraishi:
The U.S. Food and Drug Administration (FDA) recognizes the importance of timely communication between U.S. and Japanese governmental authorities on matters useful to preserving the safety, quality, and efficacy of pharmaceutical products in the markets of the United States and Japan. FDA has high regard for the critical role of the Japanese Ministry of Health and Welfare (MHW) in the collection and use of information about pharmaceutical products manufactured and distributed in Japan. The intentions expressed in your letter of December 22 are acceptable to FDA. "Pharmaceutical products" means those products, including active ingredients, that are defined as "drugs for human use" in both countries and to which Good Manufacturing Practice (GMP) requirements of the respective countries are applied. The definition of pharmaceutical products above includes active ingredients.
By this letter FDA intends to:
- Provide upon request copies of inspection reports and product sample test results describing the conformity of a pharmaceutical product manufacturing facility located in the U.S. to FDA’s current GMP requirements.
- Restrict to information already routinely collected and maintained for pharmaceutical products which have already been approved for marketing and distributed in the importing country.
- Exclude information collected as part of a pre-marketing approval evaluation process.
- Work with MHW on the development and maintenance of a joint inventory of pharmaceutical product manufacturing facilities located in Japan and the U.S., including a list of pharmaceutical products made at each facility.
- Provide information on FDA-classified recalls of pharmaceutical products known by FDA to have been manufactured or distributed in Japan.
- Respond to MHW requests for other pharmaceutical product quality information. Provide such information when able to do so or explain why such information cannot be provided.
- Permit MHW access to FDA's GMP compliance status database for U.S. pharmaceutical manufacturing facilities.
- Protect any information received from MHW to the extent permitted under FDA regulation (Title 21, Section 20.89 of the U.S. Code of Federal Regulations) and provide MHW with copies of U.S. laws and regulations governing FDA's ability to maintain information as confidential.
- Generally provide all information described above in a manner fit for public dissemination under U.S. laws and regulations. FDA will consider providing specifically requested non-public information only in accordance with established U.S. laws and regulations.
- Welcome MHW officials where appropriate for the purpose of studying the implementation of the FDA GMP regulatory system, as resources permit.
- Appoint a liaison(s) for the exchange of information and other communications between FDA and MHW. The FDA liaison(s) will notify the designated MHW liaison(s) of any concerns or problems with the provided information described in this letter and work diligently to resolve these as well as all MHW concerns.
- Review the progress and benefits of the information exchange and meet with the MHW at least once every three years to discuss this exchange.
All activities described in this letter are to be carried out consistent with the laws and regulations applicable to each country.
FDA intends to provide three months notice to MHW before ceasing or changing any of these activities. If these activities are to be changed, FDA intends to review those changes, consulting with the Department of State.
It is my hope that this letter will serve to enhance the continued beneficial and productive relationship between the MHW and the FDA. FDA looks forward to a future time when both governments are ready to build further on the feelings of trust and cooperation that have led to the cooperation described in this letter.
Sharon Smith Holston
for International and Constituent Relations