An agreement between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on mutual recognition of drug facility inspections may be signed in January 2017. And there are consequences for the MDSAP scheme for medical devices.
In a recent report by the EU Commission (*) "The state-of-play and the organisation of the evaluation of the US and the EU GMP inspectorates were discussed. In light of the progress achieved, the conclusion of a mutual recognition agreement of Good Manufacturing Practices (GMPs) inspections by January 2017 is under consideration." Such an agreement would set a significant precedent for a similar agreement on medical device inspections, most likely based on the MDSAP scheme.
An EMA-FDA MRA?
There are three reasons to doubt the conclusion of a mutual recognition agreement (MRA)...
- Some issues are still not resolved - for example, the exchange of confidential information and the inclusion of veterinary products in the scope of the text,
- The TTIP (Transatlantic Trade and Investment Partnership) negotiations have faltered and neither side seems interested in pursuing them (despite all the work done), and
- There is no possibility now of concluding negotiations before the end of the Obama presidency, which was keen to conclude a deal. And Trump, it seems, rejects all international trade deals.
However, the inevitability of an EMA-FDA MRA seem certain - regulatory bodies are collapsing under the pressure of the inspection workload, especially the FDA with its global reach. If nothing else in TTIP survives, this will; its only a matter of when. Our guess: 2018.
The knock-on effects for the roll-out of the MDSAP for Medical Devices scheduled for 2017 is, as yet, unknown. We will watch keenly for news on this topic.
(*) The "Report of the 15th Round of Negotiations for the Transatlantic Trade and Investment Partnership" summaries the 15th round of negotiations for TTIP from 3rd to 7th October 2016 in New York.