Regulatory Services in UK

Looking for expert Regulatory Affairs Services in UK? The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK is an executive agency of the Department of Health and Social Care, responsible for ensuring that medicines and medical devices work and are acceptably safe. The MHRA includes the Clinical Practice Research Datalink (CPRD) and the National Institute for Biological Standards and Control (NIBSC), all functioning synergistically to regulate medicinal products. CPRD is a pre eminent UK real world research service delivering anonymised NHS primary care data for observational and interventional studies. NIBSC is responsible for standardisation and control of biological medicines, offering reference materials, testing, applied research, and training

Additionally, the MHRA oversees partner organisations and other agencies to monitor and evaluate medicinal product regulation and promote patient safety. It assesses marketing authorisations, regulates clinical trials, operates pharmacovigilance systems (e.g. Yellow Card Scheme), and enforces compliance with statutory obligations

The MHRA works closely with the European Medicines Agency (EMA), although significant changes occurred post Brexit. MHRA issued licences are no longer recognised in the European Union (EU), presenting challenges for manufacturers seeking EU market authorisation. MHRA’s participation in EU clinical trials has also become uncertain. Consequently, the MHRA has implemented requirements for registration of clinical trials and for importing Investigational Medicinal Products under its jurisdiction.

The MHRA works closely with the European Medicines Agency (EMA), although significant changes occurred post Brexit. MHRA issued licences are no longer recognised in the European Union (EU), presenting challenges for manufacturers seeking EU market authorisation. MHRA’s participation in EU clinical trials has also become uncertain. Consequently, the MHRA has implemented requirements for registration of clinical trials and for importing Investigational Medicinal Products under its jurisdiction.

In October 2020, the MHRA joined the Access Consortium, a coalition of national regulatory authorities from Switzerland, Singapore, Canada, Australia, and the UK, to support global cooperation. Member agencies work via work sharing initiatives such as the New Active Substance Work Sharing Initiative (NASWSI), biosimilars and generic medicine review processes, enabling efficiency and reducing duplication while each regulator retains sovereign decision making

The consortium aims to maximise international co operation, align regulatory systems, and increase regulatory capacity, thereby ensuring timely access to high-quality, safe and effective medicinal products for patients.