EUROPEAN UNION REAFFIRMS STANCE ON BATCH TESTING OF PRODUCTS FROM COUNTRIES WITHOUT MUTUAL RECOGNITION AGREEMENTS; REQUIREMENT NOT UNIFORMLY ENFORCED
Executive Summary
Batch testing will continue to be required for pharmaceutical products from countries that do not have a mutual recognition agreement with the European Union, EU representatives told FDA officials at a fourth round of talks on MRAs April 10-12 in Washington, D.C. U.S. and EU reps met to discuss the possibility of having MRAs covering a variety of areas, including drug Good Manufacturing Practices and Good Laboratory Practices.