News story

MHRA publishes new guidance to help applicants and shorten timeframes for assessment of established medicines

Process changes from 1 March 2024 build on measures already implemented by the agency

Process changes for the assessment of established medicines have been published today by the Medicines and Healthcare products Regulatory Agency (MHRA), in new guidance which will come into effect on Friday, 1 March 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.

The new guidance builds on other measures already introduced by the MHRA. Applications submitted before 1 January 2024 and awaiting first assessment, have the opportunity to convert to the agency’s new Mutual Recognition and Decentralised Reliance Procedure (MRDCRP) or the European Commission Decision Reliance Procedure (ECDRP). The MHRA has also taken steps to help ensure that applications are complete on submission, to eliminate the most frequently seen deficiencies.  

The timely processing of marketing authorisation applications for established medicines is of the highest importance. The measures the MHRA is putting in place are already resulting in significant improvements, and the agency will continue to publish monthly updates providing applicants with transparent information on expected timescales.

Further information

  1. New MHRA guidance has been published here
  2. “Established Medicines” include products that are not new active substances or line extensions to new active substances. This process change applies specifically to ‘chemical’ products (i.e. excludes ‘biosimilars’).
  3. The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.  All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.

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Published 28 February 2024