December 22, 2000
Ms. Sharon Smith Holston
Deputy Commissioner for International and Constituent Relations
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
United States of America
Subject: Exchange of Certain Information on Pharmaceutical Products
Dear Ms. Holston:
This letter concerns cooperation in the exchange of pharmaceutical inspection reports and other pharmaceutical surveillance information between the Inspection and Guidance Division, Pharmaceutical and Medical Safety Bureau, Ministry of Health and Welfare (MHW), Japan, and the Food and Drug Administration (FDA), United States of America.
MHW would like to begin exchanging inspection reports and surveillance information on pharmaceutical products. "Pharmaceutical products" means those products 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" includes active ingredients. Recognizing this information sharing as an initial step to expand cooperative activities and enhance understanding of each other’s systems, the Inspection and Guidance Division, MHW 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 Japan to MHW’s current GMP requirements.
- Restrict to information which is 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 FDA 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 MHW-classified recalls of pharmaceutical products known by MHW to have been manufactured or distributed in the U.S.
- Respond to FDA requests for other pharmaceutical product quality information. Provide such information when able to do so or explain why such information cannot be provided.
- Provide all communications in English.
- Protect any information received from FDA to the extent permitted by Japanese laws and regulations and provide FDA with copies of Japanese laws and regulations governing MHW's ability to maintain information as confidential.
- Generally provide all information described above in a manner fit for public dissemination under Japanese laws and regulations. MHW will consider providing specifically requested non-public information only in accordance with established Japanese laws and regulations.
- Welcome FDA officials where appropriate for the purpose of studying the implementation of the MHW GMP regulatory system, as resources permit.
- Appoint a liaison(s) for the exchange of information and other communications made between MHW and FDA. The MHW liaison(s) will notify the designated FDA 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 FDA concerns.
- Review the progress and benefits of the information exchange and meet with FDA 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.
MHW intends to provide three months notice to FDA before ceasing or changing any of these activities. If these activities are to be changed, MHW intends to review those changes, consulting with the Ministry of Foreign Affairs.
Please let us know at your earliest convenience whether these intentions are acceptable to FDA.
Inspection and Guidance Division
Pharmaceutical and Medical Safety Bureau
Ministry of Health and Welfare