MHRA publishes new guidance established meds assessment
Process changes for the assessment of established medicines have been published by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), in new guidance which will come into effect on Friday March1, 2024.
The changes will enable the agency to assess applications more efficiently, helping to ensure a smoother and more rapid approvals process for applicants.
At the heart of the changes are a ‘technical completeness check’ designed to ensure that the MHRA has all the necessary information to proceed with its assessment at the start of its review.
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