"Lack Of Effort" Over US/EU MRAs: PhRMA

11 May 1997

There does not seem to be a real effort now to conclude the US/EuropeanUnion Mutual Recognition Agreements on the harmonization of regulatory standards, Pharmaceutical Research and Manufacturers of America senior vice president for international affairs, Harvey Bale, has told a meeting on international issues (see also pages 16-17). MRAs relating to pharmaceuticals and medical devices need to be completed before a package of seven MRAs can be accepted.

The US Food and Drug Administration says some progress has been made with issues such as timing, transition and the scope of the MRAs relating to drugs, but the PhRMA feels the fact that recent negotiations have been carried out over the phone rather than face-to-face indicate a lack of effort. Progress in the talks slowed down when some FDA officials who were not involved previously then took part, he said. There are also FDA concerns that the Europeans are not committed to ending batch testing at borders.

There are divisions within the EU Commission over outstanding issues on both sides, and also within the FDA, Mr Bale noted. Some major policy decisions need to be made on both sides. The FDA has a problem with the structure of the agreement, in that the Commission wants an umbrella agreement to set up an overbody which the FDA feels might countermand other decisions.

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