Regulatory Blog

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 webi

The UK medicines regulatory framework provides structured pathways for obtaining a licence to market a medicinal product. Two key guidance documents outline the National Assessment Procedure (NAP) and the process to Apply for a licence to market a medicine in the UK . Together, these resources explain how applicants can submit, manage, and progress marketing authorisation applications within the UK regulatory system. Guidance: National Assessment Procedure (NAP) for Medicin

The Medicines and Healthcare Products Regulatory Agency (MHRA) has introduced a " National Assessment Procedure for Medicines " for...