MHRA no longer receiving EMA assessment contracts

The Medicines and Healthcare products Regulatory Agency (MHRA) is no longer being allowed to accept European Medicines Agency (EMA) assessment work because it cannot commit to being available should assessment processes extend beyond March next year. The MHRA obtained only two contracts this year, despite being the leading national body providing assessments to the EMA in 2016.

Post-Brexit, the MHRA will need to assess all new medicines on behalf of the UK, as EMA assessment will no longer be accepted. The loss of around £14m (of a total budget of around £170M) in funding from conducting EMA work will need to be made up from elsewhere, at same time the MHRA takes on a significantly expanded workload.

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Published 3. September 2018 in News, News EU, News UK