The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) have released further guidance on how a no-Brexit deal will effect clinical trials, namely:
- The regulation of medicines
- The regulation of medical devices
- The regulation of clinical trials
The scenario of a so called “Hard Brexit” is still a possibility and people need to make the necessary preparations. The MHRA responded to the recent EU exit no-deal legislative proposals, the MHRA issued an updated guidance defining some of the proposed arrangements if the U.K. will leave the European Union on the 29th of March 2019 with no deal.
For clinical trials of investigational medicinal products (IMPs), some of the key arrangements include the following:
- The European regulatory network
- Sponsor or legal representative
- Regulatory framework
- The testing and certification of IMPs
- Import licensing
- Safety reporting
- Clinical trials applications
- Publishing trial results
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