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FDA AND EUROPEAN COMMISSION DISCUSSING GMP MEMORANDUM OF UNDERSTANDING

Executive Summary

FDA AND EUROPEAN COMMISSION DISCUSSING GMP MEMORANDUM OF UNDERSTANDING agreement that would apply to all 12 countries that are members of the European Community. Representatives from FDA and the Commission of the European Communities' Directorate General for the Internal Market and Industrial Affairs addressed the development of the good manufacturing practices agreement at the Second Bilateral meeting held March 29-30 at FDA's headquarters in Rockville, Maryland. A joint statement on the meeting says that the two groups agreed to "the initiation of activities toward the development of a Memorandum of Understanding (MOU) on Good Manufacturing Practices (GMPs)." According to FDA, the agency and the EC contingent concluded that they ought to "start working more diligently" in trying to create such an agreement. One of the commission's highest priorities is to develop an inspection and enforcement system to ensure that all member countries are complying with GMP standards. The commission told FDA that it would discourage its member countries from negotiating any new MOUs with other countries, but that existing agreements would remain in effect until the EC can develop one as a replacement. FDA currently does not have any MOUs on GMPs with EC countries; however, the agency has such arrangements with Switzerland, Sweden and Canada. FDA and the EC commission's discussion also applied to MOUs for Good Laboratory Practices (GLPs). FDA has GLP agreements with several EC countries, including West Germany, France, Italy, the Netherlands and the U.K. The agency also has GLP MOUs with non-EC members Japan, Canada, Sweden and Switzerland. FDA and the EC commission also formally agreed to share information on product hazards and changes in regulatory status, such as changes in indications for use. The two groups informally have been exchanging such information for about one year. Former FDA Commissioner Young and seven other agency officials attended the First Bilateral meeting, which took place in Brussels in November. Both bilateral meetings consisted of a plenary session and smaller discussion groups on specific topics. The next bilateral meeting will be held in Brussels in the fall/winter of 1990. A conference co-sponsored by FDA, the EC, Japan and the International Federation of Pharmaceutical Manufacturers Associations is also planned for 1991, the joint statement says. The groups will discuss "the harmonization of technical and scientific requirements in drug development." * HHS Undersecretary Constance Horner reported on the intergovernmental meeting during a Q&A period at the Pharmaceutical Manufacturers Association annual meeting in Boca Raton, Florida on April 2. Asked to comment on the HHS response to the globalization of private sector drug R&D efforts, Horner noted that "within the FDA, in particular, the agency has been working with its counterparts in Japan and the European Community to try to harmonize regulations." FDA's meeting with the Europeans comes one month after a similar session with a Canadian delegation from the Health Protection Branch of Health and Welfare Canada. That meeting, on Feb. 20, was initiated by the Canadians "to determine the differences" in current drug and biological review procedures and to "identify areas for potential harmonization." The Canadians are expected to send a letter to FDA by the end of April summarizing their view of the meeting and proposing a plan for having each country study the existing regulations and policies of the other.
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