National Assessment Procedure for Medicines in the UK

Overview

The National Assessment Procedure is the process for evaluating marketing authorisation (MA) applications for medicines across the United Kingdom. The procedure is designed to assess whether medicines meet the required standards of safety, quality and efficacy before approval. It applies to both innovative and established medicines submitted as national MA applications.
Source: National assessment procedure for medicines - GOV.UK (gov.uk)

Innovative Medicines

Innovative medicines include:

• New active substances (NAS) not previously authorised in a medicinal product in the UK
• All biological products, including advanced therapy medicinal products (ATMPs), vaccines and biosimilars
• New combinations of existing active substances
• Orphan medicinal products
• Conditional MAs or MAs under exceptional circumstances
• Line extensions of the above
  Source: National assessment procedure for medicines - GOV.UK (gov.uk)

Timetables

The procedure sets timelines for decisions:

• For innovative medicines, the aim is to reach a positive decision within 150 clock-on days if issues are resolved after one round of questions. Where issues remain at day 150, a final decision is made as soon as possible and within 210 clock-on days.
• For established medicines (those not meeting the innovative criteria), a final decision is targeted within 210 days of the start of assessment.
  Source: National assessment procedure for medicines - GOV.UK (gov.uk)

Pre-Submission and Scientific Advice

Before submitting an MA application under the national assessment procedure, applicants can ask the MHRA (Medicines and Healthcare products Regulatory Agency) for scientific advice at any stage of the medicine’s development to help clarify data requirements and regulatory expectations.
Source: National assessment procedure for medicines - GOV.UK (gov.uk)

The guidance also notes that UK paediatric requirements may apply, and that product names in applications should be considered to ensure safe and correct use.
Source: National assessment procedure for medicines - GOV.UK (gov.uk)

Submission Portal

All MA applications under the national assessment procedure must be submitted through the MHRA Submission Portal. Applicants should refer to related guidance on registering to make submissions to the MHRA.
Source: National assessment procedure for medicines - GOV.UK (gov.uk)

Established Medicines

For medicines that do not qualify as innovative under the guidance, the national assessment procedure also applies, but the timeline for decision is generally within 210 days, with opportunities for earlier decisions if only minor issues arise.
Source: National assessment procedure for medicines - GOV.UK (gov.uk)

Interaction with Other Procedures

The guidance should be read alongside other MHRA guidance on submission and assessment timetables for innovative medicines applications, which gives more detailed deadlines and pre-submission recommendations.
Source: Submission and assessment timetables for innovative medicines applications - GOV.UK (gov.uk)