Why might I need a Scientific Advice Meeting?
Do you have any questions for the MHRA about the clinical development of your medicine, strategy for a Marketing Authorisation Application (MAA) or looking at a reclassification? Then you may benefit from a scientific advice meeting (SAM) with the MHRA. This article provides an outline of where to start and and how to request a meeting following recent updates to the process.
You can request a meeting:
- To address a scientific query or queries on an individual product (e.g. clinical trial design, or specific CMC requirements) – ‘Scientific advice’ meeting
- Or request a broader scope meeting that is not product specific (e.g. general approach to product development) – ‘Broader scope advice’ meeting
You can also choose to ask for a joint SAM with the MHRA and National Institute for Healthcare and Excellence (NICE) if this is more appropriate for your product.
MHRA recent updates
The MHRA has made some shifts in how they handle Scientific Advice, and here’s what you need to know:
Less meetings, more written responses: To improve efficiencies, the MHRA will be reviewing any requests in more detail to establish if a meeting really is needed, or if written advice is suitable. More requests will be handled through written advice from their experienced team. This means you really need to develop and clarify your questions before submission. Ensure your questions are thorough and well thought out, your data is solid, and your proposals are clear.
If you receive written advice, you can ask for clarification by email.
They’re thinking bigger picture: The MHRA is putting their energy into strategic advice, especially for treatments that address serious unmet needs or cutting-edge therapies. If you’ve got detailed, questions or overall strategy queries, you might be better off initially reviewing these with external consultants like Fusion Pharma. This may help you answer some questions immediately, and ensure that you develop targeted questions and really get the answers and direction that you need.
Payment changes: You’ll need to pay for your advice at least 3 weeks before any meeting date – no exceptions (unless your company has SME status).
How do I request a meeting?
The MHRA ‘Ask for scientific advice form‘ guides you through the steps to request a meeting and a number of supporting documents should be submitted with the request. The MHRA will not process receipt of your request for scientific advice until you send them a full and complete list of questions to be asked. Once you have a meeting, you must send your final questions list and briefing document to the MHRA at least 15 working days before the meeting date.
What happens during the meeting and after?
If the meeting is a Scientific advice meeting, the meeting is usually scheduled for 90 minutes. The format of these meetings can vary but will be mutually agreed in advance. It usually works that the company deliver a short presentation, followed by discussion and questions with the relevant MHRA assessors at the meeting. You should take notes during the meeting. The MHRA will send you written advice within 30 working days of the meeting.
If the meeting is a Broader scope advice meeting, the meeting is usually scheduled for 90 minutes. The format of these meetings can vary but will be mutually agreed in advance. It can include experts and patient representatives. It may be that the company deliver a short presentation, followed by discussion with the wider group at the meeting. It is important that you take notes during the meeting. Since these meetings are wide-ranging and speculative, the MHRA does not provide written advice afterwards.
If the meeting is a Joint scientific advice with the MHRA and NICE, the meeting is usually scheduled for 3 hours. You can discuss clinical study designs that meet both regulatory and NICE’s health technology assessment requirements. After the meeting, the MHRA and NICE will each produce separate advice documents to answer the respective questions raised within 30 working days of the meeting.
Once you receive the written advice, you can ask for clarification by email.
Note: The scientific guidance provided by the MHRA is not legally binding for any subsequent application of the product in question, either by MHRA or the Applicant. The guidance cannot be considered indicative of any future agreed position. The MHRA’s responses are based on the questions submitted and accompanying documentation and cannot account for future changes and developments in scientific understanding or regulatory requirements.
What is the cost for a meeting?
The fees for a scientific advice meeting can be found here. You must pay at least 3 weeks before your meeting date. A waiver from scientific advice fees is available to UK based Small and Medium-Sized Enterprises (SME). You can refer to our blog on SME status for the UK and we can support you gain this.
If your UK-based company could be classified as a SME (you can apply here), or already has SME status, then your company is eligible to apply for a waiver from scientific advice fees.
Our regulatory experts have been involved in many scientific advice meetings and can provide you with in-depth support and guidance, also someone to take the technical meeting minutes if needed. If you would like to discuss how Fusion Pharma can support you with requesting Scientific Advice, please email us at hello@fusion-pharma-limited.com or phone us on +44 (0) 203 1379 799.
SAM Case Study
A company requested Fusion to support them through a SAM with the MHRA, from beginning to end of the process. This involved us listening closely to our client to understand what their queries were and what their desired outcomes might be. We then reviewed the proposed strategy, discussed our approach, carefully crafted the questions and applied for the SAM.
Tip: it’s really important to carefully consider which questions to ask and how to ask them so that you get the most clarity from the MHRA.
10 weeks following receiving the SAM reference number and fees request we received a date for the SAM – the date set was exactly 6 months from the request.
This may seem like a long time to wait but there is a lot of work to be done prior to the SAM!
How did we use this time?
- Complete, and submit to MHRA, the list and details of SAM attendees (see tip below) from Fusion and our client.
- Prepare final briefing documents*
- Prepare final list of questions*
- Prepare slide deck*
*All of these documents were submitted to MHRA 3 weeks prior to the SAM.
Tip: our client wished to have a face-to-face meeting with the MHRA but the MHRA usually offers meetings via Teams.
Fusion developed a comprehensive timeline to guide the countdown to the SAM and facilitated several targeted meetings, leveraging our UK regulatory expertise to ensure all required documentation and presentations met the highest standards. We conducted a thorough meeting rehearsal to ensure the client felt well-prepared and confident when presenting the company’s position on key questions. Fusion provided strategic guidance on which elements to emphasise, enabling clear and compelling presentation that effectively supported the company’s position on each question raised.
Tip: it is expected by the MHRA that each person attending the SAM from the applicant side will have a tangible contribution to make during the meeting – this could be as a presenter, explaining the company position to a question or taking technical minutes. Usually regulatory affairs colleagues are present but also medical or pharmaceutical colleagues, or others depending on the questions.
Expect the unexpected!
2 weeks before the SAM was due to take place we were informed of a delay of 2 months. This was, of course, most disappointing for our client. Fusion successfully negotiated with MHRA and brought this forward by 1 month.
On the day
On the day of the SAM, Fusion facilitated the meeting from the company side, ensuring that all questions were thoroughly addressed and comprehensively answered, whilst monitoring time keeping.
Tip: as the meeting is likely to be only 90 minutes it is important to ensure your questions are dealt with in order of priority to ensure you come out with answers to your most important questions.
Fusion prepared the technical minutes of the SAM, confirmed content with our client and submitted them to the MHRA. The MHRA then provided their final scientific advice in writing (this can take up to 30 working days to receive).
Tip: on the day take a breath after the meeting then reconvene straight away to give initial thoughts on how it went. It is important that each attendee give their thoughts as sometimes different people focus on different aspects.
What the client said
“We are confident in the experienced team at Fusion. They know the UK regulatory landscape and we trust their advice.”
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.
