US FDA's Relations With The Rest Of The World

The USA no longer sets the world drug approval standard, Richard Kinghamof Covington and Burling told the Food and Drug Law Institute (Marketletter December 23, 1996); the new European Medicines Evaluation Agency has consciously chosen to set its own model for approval and review, specifically rejecting some US standards.

To ensure entrance to foreign markets, international harmonization and a common standard for submissions has become the goal, he said. Mutual recognition is tougher than harmonization as it requires a surrender of national sovereignty. Given the global economic changes, the USA must be prepared to be objective and learn from other countries' experiences, he said.

MRAs And CTDs Of Concern In USA And EU Drug firms need international harmonization on intellectual property, trade and the marketplace, said Richard Saul, the Pharmaceutical Research and Manufacturers of America's international deputy vice president; the PhRMA and government are working to open new markets, and PhRMA is encouraging market-driven competition abroad. Two areas of concern in the USA and the European Union are Mutual Recognition Agreements on Good Manufacturing Practice inspections, and Common Technical Dossiers. The PhRMA has endorsed MRAs, which hold the promise of greater economies of scale without sacrificing quality. CTDs, harmonizing the safety and efficacy contents and format of a global application acceptable to all, would lower costs and speed drug approvals. He hoped the fourth International Conference on Harmonization, in July 1997, would begin to deal with CTDs.