UK And EMA Could Work Together Informally After Brexit
The UK may not be able to participate in the European Medicines Agency after Brexit, but there are plenty of precedents for informal collaboration among regulatory agencies worldwide. A former European Medicines Agency executive director and legal experts talk to the Pink Sheet about what might be possible.
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Uncertainty about Brexit's impact on the FDA-EMA mutual recognition agreement are among issues worrying regulators as countdown continues to the UK's departure from the EU.
The UK regulator is realistic about the threats Brexit poses to its income and influence, but is confident it can set up a standalone regulatory system and has some ideas for working with the European Medicines Agency under the future relationship between the UK and the EU.
As Brexit uncertainty continues and a “no-deal” scenario remains a possibility, pharmaceutical companies need to be looking at issues such as the renegotiation of supplier contracts, the transfer of key regulatory roles, and the mapping of trade flows, says EFPIA’s president, Stefan Oschmann. Meanwhile, industry and healthcare organizations have drawn up a list of “crucial unanswered questions” that they say the Brexit negotiators must address.