FDA, EU Moving Forward on GMP Inspection Mutual Agreement
FDA and the European Union are moving forward with a GMP inspection mutual agreement to recognize each other’s inspectional activities, with such an agreement being finalized in January. The agreement is part of the negotiations under the Transatlantic Trade and Investment Partnership (TTIP). There are still a number of issues that are being discussed between the parties, such as the scope of the provisions and operational implementation, according to a new TTIP report.
Recent negotiations covered the scope and definitions under the agreement, and the exchange of confidential information between regulators and regulatory cooperation. “As in the previous round, the EU reiterated the importance of agreeing on solid regulatory cooperation provisions,” the report says. “On its Article 6, the EU stressed the need to maintain clear commitment to work in areas of strategic interest (Article 6.2) and collaboration on anti-microbial resistance (Article 6.3). The EU reiterated its interest to include veterinary products in the scope of the text.”
On medical devices, an EU proposal for an annex and a U.S. proposal were discussed in detail, according to the report. “The EU text comprises the main elements discussed with the U.S. during the previous TTIP negotiation rounds (the unique device identification, the regulated product submission and a place holder on the single audit of quality management systems),” it says. “The EU text proposal contains additional elements which have not been discussed under the TTIP in the past but the EU considers important from a regulatory perspective, namely cooperation on exchange information on non-compliant medical devices and cooperation on standards. The EU and the U.S. proposals for an annex on medical devices have been put side by side in order to identify commonalities. For some provisions, notably the unique device identification, the regulated product submission and the single audit first attempts of common language have been discussed. Article 4 and 5 on collaboration in international organizations and implementation of international standards were also discussed in detail. Other issues discussed include the scope and definitions, exchange of confidential information between regulators, cooperation on standards, regulatory cooperation as well as U.S. proposals not covered in the EU text. As in the previous round, the EU reiterated the importance of agreeing on solid regulatory cooperation provisions and to maintain a clear commitment to work in areas of strategic interest.”