The regulatory landscape for pharmaceuticals is constantly evolving, and the UK Medicines and Healthcare products Regulatory Agency (MHRA) has introduced updated "Guidance Established medicines: marketing authorisation application changes".
Marketing authorisation is a legal requirement for any medicinal product to be placed on the market. It ensures that medicines are safe, effective, and of high quality.
For established medicines—those already authorised and marketed—the MHRA has introduced changes to simplify application processes while maintaining robust regulatory oversight. The updated procedures apply specifically to chemical products that are not new active substances or line extensions to new active substances. Notably, biosimilars are excluded from these changes.
The MHRA has implemented several pivotal changes to the MAA process:
Non-Processing of Incomplete Applications: The MHRA will no longer process applications that are incomplete. Applicants must ensure that all required documentation and data are submitted correctly at the time of application to avoid delays or rejections.
Single Request for Further Information (RFI): The agency will issue only one RFI during the assessment process. Applicants are expected to provide comprehensive and accurate responses within the specified timeframe. Failure to adequately address the RFI may result in application refusal.
UK Public Assessment Reports (UKPAR): Following approval, applicants are required to submit a pre-populated template containing a lay summary for the UKPAR. This initiative aims to enhance transparency and public understanding of approved medicines.
These process changes took effect on 1 March 2024 and will remain in place until further notice. The MHRA has committed to reviewing and, if necessary, refining these processes after a three-month period to ensure their effectiveness and address any emerging issues.
The updated guidance benefits pharmaceutical companies by reducing administrative burdens and expediting approval timelines for minor and moderate variations. However, companies must ensure compliance with new documentation standards and leverage digital tools effectively for submissions. Once marketing authorisation applications are approved, companies must adhere to post-authorisation obligations, including:
Regular pharmacovigilance reporting to monitor safety profiles of medicines.
Timely implementation of approved variations across all markets where the product is sold.
Communication with healthcare professionals regarding any updates affecting patient care.
In conjunction with these changes, the MHRA has introduced several supportive measures:
Conversion Opportunities: Eligible national MAAs submitted before 1 January 2024 that are awaiting first assessment may convert to the Mutual Recognition and Decentralised Reliance Procedure (MRDCRP) or the European Commission Decision Reliance Procedure (ECDRP).
Application Checklists: To assist applicants in achieving "right-first-time" submissions, the MHRA has provided detailed checklists outlining the necessary components of a complete application.
Common Application Flaws: The agency has identified frequent deficiencies in applications, particularly concerning bioequivalence issues, inappropriate use of biowaivers, product specifications, dissolution methods and limits, and impurities testing, including assessments for nitrosamines content. Applicants should pay close attention to these areas to enhance the likelihood of approval.
The MHRA is dedicated to transparency in its operations and publishes monthly performance data related to regulatory decisions on various application types. Applicants can access the latest performance metrics to stay informed about processing times and approval rates.
By adhering to these updated guidelines, applicants can facilitate a smoother approval process, ultimately ensuring that safe and effective medicines reach patients without unnecessary delays.
For comprehensive details and further guidance, please refer to the official MHRA documentation by clicking this LINK.
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