Progress on mutually recognizing GMP inspection has been ongoing since June, particularly as the US Food and Drug Administration (FDA) has observed at least eight audits since 2014 and as six additional audits were planned for 2016 (Austria, Estonia, Lithuania, Malta, Romania, Spain), while audits of 12 additional EU countries are planned for 2017, according to a European Medicines Agency (EMA) spokeswoman. Currently, EMA has such mutual recognition GMP agreements in place with Switzerland, Australia, New Zealand, Japan, Canada (with some limitations) and Israel (with some exclusions).
A major sticking point for both FDA and EMA is the question of trade secret information (inspections typically involve specifications of manufacturing equipment and processes for manufacturing drugs that are proprietary information).
The negotiations on the GMP inspections, which took place from 3 October to 7 October, 2016 in New York, are part of a larger trade deal between the US and EU, where other potential areas for pharmaceutical and medical device regulatory harmonization are under discussion.
Beyond the mutual recognition of GMP inspections, the EU reports that there are a number of matters still to be agreed upon/discussed, particularly with respect to the scope of the provisions and operational implementation. “For some provisions, first attempts of common language have been discussed. The EU raised in particular its Article 4 and 5 on collaboration in international organizations and implementation of international standards and Article 6.1 on medicinal products authorization. Other issues discussed include the scope and definitions, the exchange of confidential information between regulators and the regulatory cooperation as well as the US proposals not covered in the EU text,” the report says.
As in the previous round, the EU says it reiterated the importance of agreeing on solid regulatory cooperation provisions. For instance, the EU stressed the need for collaboration on antimicrobial resistance and reiterated its interest in including veterinary products in the scope of the pharmaceutical text. On the device side, the EU proposal for an annex was discussed in detail, as was the US proposal, which included unique device identification, the regulated product submission, and a place-holder on the single audit of quality management systems. The report also notes that EU and the US 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,” the report says. “Other issues discussed include the scope and definitions, exchange of confidential information between regulators, cooperation on standards, regulatory cooperation as well as US proposals not covered in the EU text.”
In addition, the EU provided an update on the state-of-play of its new medical device regulations, indicating that the two texts were agreed by the co-legislators in mid-June.
REFERENCE: RAPS Regulatory Focus; 26 OCT 2016; Zachary Brennan