The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced process changes in its latest guidance aimed at enhancing the efficiency of assessing established therapies.
Set to come into effect on 1 March 2024, the guidance incorporates these changes to streamline the approvals process for applicants.
The new guidance stipulates that the regulator will not process incomplete applications. One request for further information will be provided, and on receipt of approval, applicants file a pre-populated summary template for the UK public assessment report.
Central to the new guidance is the introduction of a technical completeness check to ensure the MHRA has all necessary information at the outset of its review.
The initiative builds upon other measures the MHRA has implemented to enhance the submission process.
Applications filed before 1 January 2024 and pending first assessment can opt to convert to the agency’s new Mutual Recognition and Decentralised Reliance Procedure or the European Commission Decision Reliance Procedure.
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The MHRA has also taken proactive steps to assist applicants in submitting complete applications, thereby reducing common deficiencies.
It emphasises the critical nature of timely processing for marketing authorisation applications of established medicines, which include products that are neither new active substances nor line extensions of new active substances.
The process change is specific to chemical products and does not apply to biosimilars.
The MHRA’s recent measures have already led to significant improvements in the processing of applications. The agency is committed to maintaining transparency by providing monthly updates on expected timescales for applicants.
The MHRA recently revoked a conditional marketing authorisation for Novartis’ Adakveo 10mg/ml concentrate for solution for infusion for the treatment of sickle cell disease.
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