Scientific Advice or Pre-submission Support? Understanding the MHRA’s Evolving Approach to Early Engagement
If you’ve worked with the MHRA in recent years, you have probably noticed that the path to regulator interaction has become more structured. The introduction of updated Scientific Advice requirements and an expanded pre-submission support framework provide greater clarity in how the MHRA expects companies to engage with the agency throughout development and before filing.
For regulatory teams, the question is no longer simply “Should we speak with the MHRA?” but rather “What is the right route for the discussion we need to have?”
Scientific Advice: More Preparation Up Front
One of the most significant changes to the MHRA Scientific Advice process is the increased emphasis on providing a complete and well-developed package at the point of request.
From September 2026, organisations are required to submit their final briefing document and questions when requesting Scientific Advice. The MHRA has also clarified its expectations regarding company positions, scientific justification, and alignment with relevant regulatory guidance.
This represents a notable change from previous UK practice, where briefing documents were often finalised after the initial request had been accepted. The new approach puts greater focus on preparation before engaging with the agency.
In practical terms, applicants should expect to:
- Clearly articulate their proposed regulatory strategy.
- Present a well-supported company position.
- Provide robust scientific justification for their approach.
- Ensure questions are focused, strategic, and decision-enabling.
The benefit is that MHRA can engage appropriate experts and the advice becomes more productive and targeted, allowing assessors to review a complete package from the outset and, at meetings, will come prepared for a meaningful discussion.
The MHRA has increasingly signalled that Scientific Advice should be used for genuine scientific and regulatory decision-making rather than procedural clarification.
This means that the greatest value is often achieved when discussing:
- Development strategies.
- Novel data packages.
- Clinical programme design.
- CMC development challenges.
- Risk-benefit considerations.
Rather than seeking confirmation of administrative requirements, companies should use Scientific Advice to obtain the agency’s views on the acceptability and adequacy of their proposed approach.
Where Do Pre-Submission Meetings Fit In?
Alongside the Scientific Advice service, the MHRA has continued to strengthen its pre-submission support offering for innovative medicines, introducing new indications and line-extensions.
This service is intended to help applicants prepare for an upcoming submission and to support the MHRA’s operational planning. If a meeting is held, they provide an opportunity to introduce the product, discuss the proposed submission approach, and identify any procedural or logistical considerations that could affect validation or assessment.
However, the updated guidance draws a very clear distinction between a pre-submission meeting and Scientific Advice.
The MHRA explicitly states:
“Pre-submission meetings may identify high-level considerations or areas requiring attention and are intended to support submission readiness. They do not constitute an assessment of the data package and must not be used to seek confirmation on the acceptability, adequacy, or sufficiency of specific scientific, clinical, or regulatory approaches. Where applicants require MHRA views on the adequacy or acceptability of their data package, development programme or regulatory strategy, a formal Scientific Advice request should be submitted.”
This clarification is important because it addresses an area that has historically caused some confusion. Where an applicant has not requested a pre-submission meeting but the MHRA considers one necessary, the MHRA strongly advises that the meeting takes place before submission. The MHRA advises that failure to attend may increase the risk of validation issues or delayed validation and assessment.
What a Pre-Submission Meeting Is Not
The updated guidance makes it clear that a pre-submission meeting should not be viewed as a substitute for Scientific Advice. It is not the appropriate forum to ask whether:
- Your clinical programme is sufficient.
- Your quality strategy is scientifically acceptable.
- The evidence is sufficient to support the proposed indication.
- The development programme or regulatory strategy is acceptable
- Those questions fall within the scope of Scientific Advice.
Instead, pre-submission meetings are designed to focus on readiness, planning, and ensuring that both the applicant and the MHRA are prepared for a successful submission.
Choosing the Right Engagement Route
A useful way to think about the distinction is:
Pre-Submission support
- “Are we ready to submit?”
- Focus on proposed route, timelines, administrative and procedural queries.
Scientific Advice
- Focus on defined scientific questions (key is what is the answer that you are looking for, and think about what answer you don’t want), company position, supporting evidence, the proposed approach.
Understanding this difference early can save significant time and help ensure that questions are directed through the most appropriate channel.
What This Means for Applicants
Taken together, these changes demonstrate the MHRA’s continued move towards more structured, efficient, and strategically focused interactions with industry.
For applicants, success increasingly depends on engaging the agency through the right mechanism at the right time:
- Use Scientific Advice when seeking MHRA views on development strategy, data adequacy, or regulatory acceptability.
- Use Pre-Submission Meetings to support filing readiness and submission planning.
- Invest more time in developing high-quality briefing packages before requesting Scientific Advice.
Ultimately, the message from the MHRA is clear: early engagement remains highly valuable, but the purpose of each interaction must be well developed. Organisations that understand the distinction between Scientific Advice and pre-submission support will be better positioned to obtain meaningful feedback, avoid unnecessary delays, and maximise the value of their interactions with the regulator.
Fusion Pharma Perspective
We have already seen these changes influence how Scientific Advice packages are prepared. The increased emphasis on clear company positions, robust justification, and fully developed briefing documents means that preparation is becoming just as important as the advice itself.
As a specialist UK medicines Regulatory Affairs consultancy, Fusion Pharma can help clients identify the appropriate MHRA engagement route, develop focused questions and company positions, and prepare clear, well-supported submission materials.
If you would like to discuss how Fusion Pharma can support you further, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.