WASHINGTON _ Talks between the FDA and the European Union(EU) on developing a mutual recognition agreement covering goodmanufacturing practices and quality controls have stalled. Presentingtheir current guidelines for such an agreement at a public meetingWednesday, FDA officials admitted that the talks have becomebogged down over issues concerning inspection reports.

Merton Smith, associate director for international agreements at theFDA said that his agency "remains committed to coming to anagreement that is consistent with our goal of protecting publichealth."

In April 1994 the U.S. and the EU began negotiations to developmutual recognition agreements (MRA) to facilitate international tradeand to coordinate regulatory efforts in order to remove redundancy ina number of areas. The growth of U.S. imports of FDA-regulatedproducts makes it desirable for the agency to rely on the GMPassessments of foreign countries. Currently, the FDA sends staffmembers overseas to inspect the manufacturing plants of companiesexporting pharmaceuticals and other FDA-regulated products to theU.S.

"With our limited resources, granting equivalencies could relieve aburden on both the FDA and industry," said Walter Batts, director ofinternational affairs at the FDA who pointed out that companies nowhave to undergo two inspections.

The FDA and EU are working to establish inspection methods thatmay not be identical but provide equivalent protection of human andanimal health and safety. Once equivalency has been established, theFDA and EU will rely upon the result of each others' inspectionmethods to insure that GMP standards are being followed.

However, the agreement is stalled over whether the EU will provideGMP inspection reports on a routine basis to the FDA afterequivalencies have been established. The EU maintains that suchreporting would result in unnecessary questions and paperwork whilethe FDA cites the fact that their statutory authority requires that theyhave these reports, Smith said.

Even if this current snag is worked out, establishing equivalencieswith the 15 member states of the EU will not be an easy task. TheFDA will have to determine that each country provides equivalentinspection and enforcement checks. The EU itself has not agreed thatall member states have equivalent practices. The equivalency processis likely to take three or more years.

Nevertheless, the Pharmaceutical Research and Manufacturers ofAmerica (PhRMA) urged the FDA to re-establish talks with the EUbecause current regulation of imports of U.S. pharmaceuticals to theEU require batch testing by labs that may or may not produceconsistent results.

"By statute, U.S. exports to the EU will be subject to batch testing,"said Richard Saul, deputy vice president at PhRMA. "This could be asignificant cost burden to companies especially if they have to provesterility."

The FDA's Smith noted that while the talks have stalled they arehopeful that an agreement on inspection reports will be worked outand that they can move on to questions of equivalencies. n

-- Lisa Seachrist Washington Editor

(c) 1997 American Health Consultants. All rights reserved.

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