The UK Medicines and Healthcare products Regulatory Agency (MHRA) is set to implement process changes, effective 1st March 2024, aimed at optimising the evaluation of established therapies.
The updated guidance emphasises efficiency by introducing a technical completeness check to ensure the MHRA receives all necessary information upfront. Incomplete applications will not be processed; instead, one request for additional information will be issued.
Upon approval, applicants must submit a pre-populated summary template for the UK Public Assessment Report.
The MHRA’s initiative complements previous measures to improve the submission process.
For applications filed before January 1, 2024, undergoing the first assessment, the option to convert to the Mutual Recognition and Decentralised Reliance Procedure or the European Commission Decision Reliance Procedure is available.
These changes are exclusive to chemical products and do not extend to biological products or biosimilars.
The MHRA, committed to transparency, provides monthly updates on expected processing timescales for applicants, reinforcing the significance of timely processing for marketing authorisations of established medicines. Notably, these alterations do not affect biological products.
The MHRA’s proactive steps have already shown substantial improvements in application processing, aligning with their commitment to transparency through regular updates on processing timescales.
The recent withdrawal of Novartis’ conditional marketing authorisation for Adakveo 10mg/ml concentrate for sickle cell disease treatment underscores the agency’s dedication to rigorous evaluation.
“MHRA streamlines approval process for established medicines” was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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