UK MHRA Guidance: National Assessment Procedure for Medicines

The UK regulatory system for medicines continues to advance towards faster access, aligned decision-making, and patient-focused innovation. The Medicines and Healthcare products Regulatory Agency (MHRA) is strengthening its national procedures to ensure efficient evaluation of medicines while improving coordination with health technology assessment bodies.

The guidance National assessment procedure for medicines was updated on 9 April 2026, including the addition of a webinar on the MHRA–NICE Aligned Pathway and Integrated Scientific Advice services, highlighting enhanced collaboration between regulatory and reimbursement frameworks.

The national assessment procedure provides a regulatory pathway for the approval of medicines in the UK outside of international reliance or decentralised procedures.

It enables the MHRA to independently assess the quality, safety, and efficacy of medicinal products before granting marketing authorisation.

This pathway plays a crucial role in ensuring timely patient access to innovative therapies while maintaining high regulatory standards.

This guidance applies to pharmaceutical companies and applicants seeking a UK national marketing authorisation for medicinal products. It covers innovative medicines, established products, and applications requiring independent UK assessment. The procedure is relevant for applicants who are not using reliance routes or international procedures and instead seek direct evaluation by the MHRA.

National Assessment Procedure

The national assessment procedure involves a structured evaluation by the MHRA to determine whether a medicine meets the required standards for approval. Applicants must submit a comprehensive dossier containing data on quality, non-clinical studies, and clinical evidence.

The MHRA reviews the submission to ensure that the benefits of the medicine outweigh its risks and that it meets regulatory requirements for safety, efficacy, and quality. This process enables the MHRA to make independent decisions tailored to the UK healthcare system.

MHRA–NICE Aligned Pathway

The MHRA–NICE Aligned Pathway is designed to improve coordination between regulatory approval and health technology assessment. It enables parallel evaluation by the MHRA and the National Institute for Health and Care Excellence (NICE), reducing delays between approval and patient access.

This pathway supports earlier engagement with both organisations, allowing applicants to align their evidence generation strategies with regulatory and reimbursement expectations. The inclusion of a webinar in the updated guidance reflects the growing importance of this integrated approach.

Integrated Scientific Advice

Integrated Scientific Advice services provide applicants with the opportunity to receive coordinated feedback from MHRA and NICE during the development of medicinal products. This approach helps sponsors design studies that meet both regulatory and health technology assessment requirements.

Early scientific advice can improve the quality of submissions, reduce uncertainties during evaluation, and support more efficient decision-making. It also encourages a more strategic approach to evidence generation across the product lifecycle.

Applicants should consider using the national assessment procedure when seeking an independent UK approval pathway and ensure that all required data is prepared in accordance with MHRA expectations. Early engagement through scientific advice services can help identify potential gaps and improve submission quality.

Utilising the MHRA–NICE Aligned Pathway can significantly reduce the time between regulatory approval and patient access, making it particularly valuable for innovative medicines addressing unmet medical needs.

References

For complete official guidance, refer to:

National assessment procedure for medicines – MHRA Guidance