Enabling decentralized manufacture for cell and gene therapies

The MHRA put legislation for decentralized manufacture before the UK parliament in 2024. The statutory instrument amendment to Human Medicines Regulations 2012 (S.I.2012/1916) (‘the HMRs’) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (S.I. 2014/1031; ‘the 2004 Regulations’) will come into force on July 23, 2025. This legislation is in response to developments in technology that the MHRA considers challenging to regulate under the current legislation which is based upon a centralized manufacturing model. Traditionally, a medicinal product or investigational medicinal product is manufactured at a central factory site and distributed from there to administration sites. In the case of cell and gene therapies, this can involve patients travelling to a specialist care center both for cell or tissue sourcing and then for administration of the drug product. There is a growing burden on health care professionals at either end of the treatment requiring specialist knowledge and experience with personalized medicine. The manufacture of autologous therapies is challenging to synchronize with related treatment for the patient. The distribution model is also strained for cell and gene therapies by shipping between sourcing centers and the manufacturing site then back to a treatment center often across national borders and different regulatory regimes.

The new legislation attempts to address these practical problems for developers, manufacturers, patients, and healthcare institutions by providing another regulatory option to adopt new technology. It supports the safe development of medicines that need to be scaled out to manufacture and supply close to patients. It builds upon the existing regulatory framework and expectations for authorized, investigational, and unlicensed medicinal products.

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