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Executive Summary

A "mutual recognition" system for approval of drug products in the European community would allow for an easier transition to a barrier-free market and be less disruptive to R&D than a supranational registry program, Merck Chairman Roy Vagelos, MD, maintained at the 14th annual assembly of the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) Oct. 5 in Washington. "Mutual recognition would assure European consumers of a smooth transition to a barrier-free market and would be least disruptive to industry research, development, and marketing programs," Vagelos stated. "This alternative would help us to avoid the major problems -- and expenses -- inherent in a transition to a single registration agency." The European group of pharmaceutical associations has been supporting a dual approach that would allow EEC (European Economic Community) companies to either submit drug marketing applications to only one country to gain approval (a mutual recognition approach) or to submit marketing applications to a central committee for review. The group sent its comments to the European Commission (EC), the government body responsible for developing a plan for EEC harmonization, in mid-September. Representatives of the U.S. pharmaceutical industry, however, are arguing that a supranational registry, even if optional, will hinder approvals. "The main drawback of the supranational agency approach, in its various forms, is that major disruption and upheaval in the European regulatory environment could result," Vagelos said, adding: "There is great potential for creating, in the short term at least, a European drug lag. Efforts to create a supranational system would inevitably result in many years of confusion and disorganization." Vagelos recommended several possibilities for regulatory reform in Europe: "A single, clearly defined set of European community standards for efficacy, safety and quality should be developed and consistently supplied"; "The determination of benefit v. risk should be made in accordance with high scientific standards established by the best European scientific experts"; "All reviews should be timely, with a binding mechanism for appeal of decisions"; "A pharmaceutical company should be permitted to select a national regulatory authority in any member state to review an application for market approval"; "All final regulatory approvals of a new chemical entity should be granted once -- then recognized by all countries [without the possibility for challenge or additional requirements]; and "There should be agreement on the principles by which the system will run before there are extensive discussions of the mechanics of how the system will function."

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