The Medicines Health Products Regulatory Agency has reaffirmed its commitment to follow the European Clinical Trials Regulation System (CTR) during the Brexit transition period, between March 2019 and December 2020.

CTR is expected to come into direct effect in all EU member states in 2019 and is designed to streamline and harmonize the application and assessment of clinical trials in the EU, including trials across multiple jurisdictions.

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The legislation is broadly supported by the UK pharmaceutical industry, and the news should provide some relief for drug companies and the NHS, which are currently increasing inventories in anticipation of the possible consequences of a no-deal Brexit.

But after transition period the music may stop

Until 2020, under the terms of the transition period, the UK is permitted the same access as present to EU databases and systems, but without being an official member state.

These systems include an EU Portal and Database for the submission and evaluation of new medicines that has been under development since 2014 and forms the backbone of CTR implementation.

Without negotiation of a bespoke UK/EU agreement, access to these systems will cease at the end of the transition period.

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And the players are already leaving

By way of guidance to those concerned, the MHRA press release promises any UK Regulatory evaluation would be the same as, or more competitive than, that of the European Medicines Agency (EMA).

According to the EMA, in a statement it made a week after the MHRA press release, “MHRA and UK ethics committees are already internationally recognised for their robust yet timely assessment of trial applications, and the UK would provide an assessment outcome no later than the European timeframe.”

The EMA is currently in the process of relocating from London to Amsterdam and expects 30% of its staff to leave because of the move, resulting in a temporary cut in services.

Ultimately, legislative harmony for the industry will still depend on whether discussions end with a soft, hard, or no-deal Brexit.

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