Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
MedEnvoy Global
The Hague, Netherlands, London, United Kingdom, United States, Switzerland, Australia
A global regulatory compliance partner specializing in in-country representation (EC Rep, UKRP, CH Rep, US Agent) and independent importer services for medical device and IVD manufacturers. We help companies navigate complex regulations in Europe, the UK, Switzerland, and the US while maintaining supply chain flexibility.
KoBridge Co Ltd
Seoul, Korea, Lausanne, Switzerland
We offer fast, effective, and flexible solutions for medical device manufacturers needing to navigate the increasing complexity of global regulations. Their core competencies cover CE Marking, FDA 510(k)/PMA, MDSAP, and especially Korea MFDS registration and KGMP compliance. They handle active, non-active, combination, and animal-origin devices, providing services from strategic planning and dossier preparation to quality system implementation (ISO 13485) and audits.
IMed Consultancy Ltd
United Kingdom, Ireland
Helping medical device and in-vitro diagnostic companies with CE marking, quality management systems, auditing, and global registrations.
January 18, 2026
Approximately 5 minutes
National Assessment Procedure for Medicines in the UK
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)
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