Advanced therapy medicinal products: regulation and licensing in UK

AI Summary

The UK Medicines and Healthcare products Regulatory Agency (MHRA) provides comprehensive guidance on the licensing of Advanced Therapy Medicinal Products (ATMPs), which encompass gene therapies, somatic cell therapies, and tissue-engineered products. Governed primarily by the Human Medicines Regulations 2012, the MHRA acts as the central authority for UK-wide regulation. While the document does not list specific company violations or inspection dates, it details the strict compliance requirements for clinical trials and Marketing Authorisation (MA). A significant upcoming change under the Windsor Framework mandates that all MA applications must be UK-wide starting January 1, 2025. Developers are directed to the MHRA Innovation Office for product classification and scientific advice. Additionally, the guidance clarifies the intersection of various regulatory frameworks, including the Human Tissue Regulations 2007 and Blood Safety and Quality Regulations 2005, involving collaboration with the Human Tissue Authority (HTA) and the Human Fertilisation and Embryology Authority (HFEA). Manufacturing entities must obtain specific licenses from the MHRA even for unlicensed products distributed through 'specials' schemes or hospital exemptions. Required actions for stakeholders include securing proper classifications, adhering to tissue procurement standards, and ensuring all applications meet the new UK-wide criteria to maintain legal compliance.