MHRA: Scientific Advice Requests Must Include Full Briefing Documents from September 2026

• From September 2026, organisations must provide full briefing documents at the point of submission for Scientific Advice requests.
• The MHRA's scientific advice service aids medicine development at any stage of a product's lifecycle or regulatory journey.
• Organisations can request specific advice on individual products or broader guidance not limited to a single development program or product lifecycle.

The MHRA's primary advice service is targeted scientific advice for individual products, while we particularly encourage organisations to request advice at the following points:

From September 2026, organisations submitting Scientific Advice requests to the MHRA must provide full briefing documents upfront. This shift in process may impact product development timelines and compliance obligations. The MHRA's scientific advice service is an advisory function that aids medicine development at any stage of a product's lifecycle or regulatory journey. Organisations can request specific advice on individual products or broader guidance not limited to a single development program or product lifecycle. Written advice can be requested, with the option for a meeting followed by a written summary of advice.

The MHRA's scientific advice process is designed to provide organisations with expert guidance on their medicine's development. The agency has extensive experience and expertise in answering questions on product lifecycles, drawing from its knowledge of regulatory requirements and scientific advancements. To access the most relevant experts and get the best advice, it's essential for organisations to send clear and specific questions in advance. The MHRA offers targeted scientific advice for individual products, with a particular emphasis on encouraging requests at key development stages.

The changes to the Scientific Advice request process may have significant implications for product development timelines and compliance obligations. Organisations must carefully plan and submit their requests with finalised questions and briefing documents to ensure timely advice. The MHRA's primary advice service is designed to provide organisations with expert guidance, but it's essential to note that scientific advice from the agency is not legally binding for future applications of a discussed product.

From September 2026, organisations must provide full briefing documents at the point of submission for Scientific Advice requests to the MHRA, which may impact product development timelines and compliance obligations.

Source: Original reporting via GOV.UK