UK MHRA Guidance: National Assessment Procedure for Medicines, Submission and Assessment timetables for Innovative Medicines Applications

The Medicines and Healthcare Products Regulatory Agency (MHRA) has introduced a "National Assessment Procedure for Medicines" for UK-wide Marketing Authorisation (MA) applications, effective from 3 April 2025. This procedure aims to streamline the assessment process for both innovative and established medicines, ensuring timely access to safe and effective medicinal products in the UK. 

National Assessment Procedure: The regulatory pathway for obtaining a UK-specific MA, as opposed to centralised or decentralised procedures used within the EU.

The national assessment procedure is one of the pathways offered by the MHRA for granting marketing authorisations (MAs) for medicines in the UK. This procedure ensures that medicines meet rigorous standards for safety, efficacy, and quality before they are made available to patients.

From 1 January 2025, the MHRA will issue UK-wide marketing authorisations under the Windsor Framework.

Innovative medicines are  Novel medicines, including new chemical entities, biological products, and advanced therapy medicinal products (ATMPs). The MHRA defines innovative medicines applications to include:​

• New Active Substances (NAS): Active substances not previously authorised in a medicinal product in the UK.​

• Biological Products: Including advanced therapy medicinal products (ATMPs), vaccines, and biosimilars.

• New Combinations: Comprising existing active substances combined in novel ways.​

• Orphan Medicinal Products: These are designed to treat rare diseases.​

• Conditional MAs or MAs under Exceptional Circumstances: Granted under specific regulatory provisions.

• Line Extensions: Such as additional strengths, pharmaceutical forms, or routes of administration for the above categories. 

For these applications, the MHRA has established a structured timetable:

• Day 0: Validation of the application.​

• Day 80: Issuance of a consolidated Request for Further Information (RFI), if necessary, leading to a clock-stop.​

• Day 150: Potential decision point if all issues are resolved after one round of questions.​

• Day 210: Final decision deadline if outstanding issues persist

The grant letter will specify any conditions of the grant, and the expiry date of the MA. MHRA publishes a UK Public Assessment Report (PAR) for all new MAs.

Established medicines refer to products that do not fall under the innovative category, typically involving generic formulations or well-characterised substances with existing therapeutic use. For these applications, the MHRA aims to reach a final decision within 210 days. However, if only minor issues are identified during the assessment, there is potential for an earlier decision, enhancing the efficiency of the approval process. 

For further information or specific inquiries regarding the National Assessment Procedure, applicants can contact the MHRA through the following channels:​

• Email: info@mhra.gov.uk

For comprehensive details and the latest updates, please refer to the official MHRA guidance on the National Assessment Procedure. 

Also, check out the "Submission and assessment timetables for innovative medicines applications" that details the deadlines for initial and response submissions.