US Pharma Industry And ICH, GATT

9 June 1996

The International Conference on Harmonization has already provided a payoff to industry, US Food and Drug Administration director of international policy Linda Horton told the Food and Drug Law Institute's Pharmaceutical Update meeting (Marketletter May 27); she hoped some of this will translate into savings for consumers.

Ansis Helmanis of Barnes Richardson and Colburn said the new drug export law's intent is unclear; it was a rider to another bill. He foresaw debate over a provision which he feels specifically exempts clinical exports from such regulation, the only requirement being export in accordance with the laws of the importing country. Ms Horton said the FDA hopes to get out a proposed rule for industry comment.

Progress on mutual recognition within both a transatlantic business dialogue program and an FDA-European Union framework was discussed, with main concerns being an EU requirement for batch testing for quality at the point of entry, and the EU's 15 different countries with different levels of competency. Mr Helmanis noted that although a single trademark is required for a centralized EU approval, trademarks must be obtained separately in each member state and a challenge in any means the product comes off the market in all. Ms Horton said the FDA will have to rely more on foreign inspections, as it cannot maintain its current levels. Harmonization efforts in the Pacific Rim area are focusing on GMP, while in the Americas they are looking at strengthening intellectual property rights.

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