EUROPEAN UNION REAFFIRMS STANCE ON BATCH TESTING OF PRODUCTS FROM COUNTRIES WITHOUT MUTUAL RECOGNITION AGREEMENTS; REQUIREMENT NOT UNIFORMLY ENFORCED

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.

During the April 10-12 meeting, EU officials did not change their stance on a new EU directive that mandates testing of batches of all products from countries that do not have an MRA with the European Union. Instead, EU reps reiterated that batch testing will be a requirement if no MRA exists. FDA said it will continue to pursue an agreement on this issue.

At a March 31 industry and consumer exchange meeting sponsored by FDA and the Animal and Plant Health Inspection Service (APHIS), industry reps urged the U.S. regulators to do what they can to bring about a change in the EU directive because it could have immediate adverse effects on U.S. drug firms.

Describing the law, SmithKline Beecham Worldwide Regulatory Compliance Transnational Regulatory Affairs Director Thomas Honohan said: "Without an MRA, all U.S. pharmaceutical companies importing drugs into the European Union can be required to do full batch testing on every batch of drug."

FDA Center for Drug Evaluation & Research Office of Compliance Director Stephanie Gray asked Honohan for suggestions on how the batch testing directive should be addressed. "It should be a focus of discussion because it's an immediate...question," Honohan replied. "If indeed the European Union wishes to put a lot of political pressure onto the system, this is one way they can do it," he added.

Honohan also noted that the new requirement is "not being uniformly applied, it's not being implemented by most countries." However, "the U.K. Medicines Control Agency now is considering invoking that rule." Honohan suggested that some European countries realize that such a requirement will cause "a lot of difficulties," and "other countries simply are not prepared to do such testing."

At an April 3-5 meeting, FDA and EU officials discussed their respective GMP programs. The agency and the APHIS met with representatives of 14 of the 15 EU member states. Canadian officials also were involved in the discussions.

FDA and the EU discussed exchanges of inspection reports of manufacturers facilities as part of an increased reciprocity of information on GMPs between the U.S. and Europe. Another topic discussed at the meeting was the possibility of FDA notification of the EU when agency inspectors are planning an inspection of a plant so that EU officials could participate as observers.

However, the EU reportedly is hesitant to start any information exchange initiatives because it continues to view GMP issues as part of a bigger package of negotiations on MRAs. Another sticking point in discussions is the EU's desire to include product approvals in MRAs.

At the March 31 meeting with industry, FDA International Affairs Staff Director Walter Batts said the agency "acknowledges the potential value of an MOU [Memorandum of Understanding] with the EU that would allow for the mutual reliance on inspection information, but believes that it can only be accomplished if the entire regulatory program in the EU is equivalent to that of FDA."

Short of that goal, "more limited agreements could be achieved in the near term that might cover such issues as joint inspections, exchange of inspection reports and joint training activities," Batts said. "FDA is in the process of publishing its policies" on MOUs, he noted.