Article summary
The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a consultation on regulatory guidance for individualised mRNA cancer immunotherapies. The guidance aims to streamline pathways for bringing these therapies to patients while maintaining robust safety principles. It covers product design, manufacture, evidence requirements for safety and effectiveness, and post-approval monitoring. The MHRA has developed the guidance with advice from the Highly Personalised Medicines Expert Working Group and may expand it to cover other highly personalised therapies in the future. Stakeholders can comment on the guidance until 31 March 2025.
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