Article summary
The Medicines and Healthcare products Regulatory Agency (MHRA) has collated the information on the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, SI 2025/87, which come into effect on 23 July 2025, in a new ‘Decentralised manufacture hub’. The hub will contain regulatory guidance to clarify expectations on decentralised manufacture once the legislation is in force. The guidance is expected to be published in early summer 2025 and will cover clinical trial authorisation and good clinical practice, designation, labelling, marketing authorisation applications and pharmacovigilance, among other issues.
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