Consultation survey - draft guideline on individualised mRNA cancer immunotherapies
Published 3 February 2025
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This publication is available at https://www.gov.uk/government/consultations/draft-guidance-on-individualised-mrna-cancer-immunotherapies/consultation-survey-draft-guidline-on-individualised-mrna-cancer-immunotherapies
Individualised mRNA cancer immunotherapies (colloquially referred to as personalised cancer vaccines) are a new type of cancer treatment that use mRNA technology.
Unlike conventional cancer therapies, each patient receives a slightly different version of the mRNA therapy which has been matched to their unique tumour fingerprint using artificial intelligence (AI). In this way, the therapy aims to teach the patient’s immune system to target and destroy their specific tumour cells. This novel individualised approach poses unique regulatory challenges, and there is an urgent need for regulatory guidance.
With this draft guideline, we aim to facilitate patient access to these novel individualised cancer therapies by outlining a clear and streamlined regulatory pathway to approval. The guidance covers product design and manufacture, evidence of safety and effectiveness, post-approval safety monitoring, and information for patients and the public. We may expand the guidance in due course to cover other types of highly personalised therapies, including for rare diseases.
We are seeking feedback from manufacturers, developers, patient organisations and other stakeholders on our regulatory approach to individualised mRNA cancer immunotherapies. This will help us to clarify and streamline pathways for bringing these therapies through to patients, without compromising on robust safety principles.
The guidance includes a section on information for patients, healthcare professionals, and the public. To make sure that patients and the public receive the right information about these therapies, we would welcome feedback on this section from members of the public including people affected by cancer.
You can find the draft guidance document here.
The consultation will close at 11:59pm on 31 March 2025.
Please respond through our online consultation survey.
Optionally, you can also leave specific line by line comments on the draft guidance. To leave such feedback, please download and refer to the guidance when completing the MHRA spreadsheet for comments. When you begin the consultation survey, you will be issued a unique identifier which you should note down in MHRA spreadsheet for comments. This is so that we can link your line-by-line response to the consultation.
The consultation questions are available here. The consultation should be completed using the online consultation survey