MHRA Unveils New Guidance to Accelerate Assessment of Established Medicines

The MHRA recently issued new guidance designed to streamline the assessment process for established medicines, implemented since March 1, 2024. The change, specifically targeting 'chemical' products and excluding 'biosimilars', is part of the MHRA's ongoing effort to expedite the marketing authorization process for established medicines and ensure timely access for patients.

The following article originally appeared in gov.uk.

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.

For more, please find the original story source here.