UK MHRA Guidance: Navigating the UK National Assessment

Understanding and navigating the UK's regulatory requirements is crucial for pharmaceutical companies aiming to obtain marketing authorisation. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance for "National Assessment Procedure for Medicines".

Released on 22 May 2025, the MHRA's latest guidance sets the stage for effective and streamlined marketing authorisation (MA) applications in the UK. Covering both innovative and established medicines, this guidance ensures that every applicant understands the intricate requirements and timelines involved.

The National Assessment Procedure (NAP) is a streamlined process designed to evaluate new medicines or new indications for existing medicines within the UK. It ensures that medicines meet the required standards for safety, efficacy, and quality before they are authorized for use.

1. Overview and Key Elements

   1. Innovative Medicines Applications:

      • Scope: This category includes new active substances, biological products, new combinations of existing substances, and orphan medicinal products. It encompasses conditional marketing authorisations and line extensions.

      • Timelines: Aimed at delivering a positive decision within 150 clock-on days, with allowances for up to 210 days if issues arise.

      • Pre-Submission Requirements: Companies should notify MHRA three months in advance and are encouraged to request pre-submission meetings for certain product types.

   2. Established Medicines Applications:

      • Scope: These are applications for medicines that do not meet the criteria for innovation.

      • Timelines: A straightforward process with a decision target of 210 days, prioritizing efficiency through first-time accurate submissions.

   
   

2. Notable Regulatory Features

   • The Windsor Framework: Adapts regulatory procedures by distinguishing medicines based on their legal classifications under UK and applicable EU law, ensuring broad compliance and clarity.

   • Fees and Payments: Fees are determined at the national rate, with a complex calculator available to guide applicants through submission costs.

3. Detailed Examination of Innovative Medicines Applications

4. Before Submission:

   • Pre-Submission Planning: A formal notification to MHRA at least three months ahead is necessary. For applications under Project Orbis or the Access Consortium, specific pre-submission processes apply.

   • Documentation: A complete electronic Common Technical Document (eCTD) must be submitted, including all relevant modules.

5. Submission and Assessment Phases:

   • Initial Evaluation (Day 90): The MHRA conducts a preliminary assessment with input from the Commission on Human Medicines (CHM) as needed. A request for further information might be issued if necessary.

   • Second Evaluation (Day 150): Applicants must address any raised questions completely. Minor issues might lead to a second request for information or advice from the CHM.

   • Final Decision (Day 210): The application reaches final compliance checks, with outcomes ranging from approval to a third evaluation request for unresolved matters.

6. Established Medicines Applications Process

7. For established medicines not meeting innovative criteria, the procedure is robust yet simplified:

   • Checklist Utilization: New process enhancements implemented since March 2024 support error-free submissions.

   • Assessment and Decision: Rigorous technical checks ensure that applications are complete. A single request for further information usually suffices if minor issues arise.

Pharmaceutical companies that understand and comply with these frameworks position themselves for successful market entry and sustained operations in the UK. For further details, consult the original guidance on the National Assessment Procedure for Medicines.