Changes to MHRA scientific advice process will result in more written responses

Article summary

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance for the review of new requests for scientific advice meetings. On 21 January 2025, MHRA began reviewing requests for meetings 'against whether the requirements can be addressed with existing guidance, written advice or a scientific advice meeting', which it states could result in an increase for a 'temporary period' in written-only responses. MHRA is planning to publish full guidance on the change on 31 January 2025. The agency is enacting the new approach alongside the launch of a series of improvements to its service and guidance, starting with the introduction of a digital application form that MHRA has designed to be 'simpler, clearer and faster to complete'.