Medicines: Get integrated scientific advice from the MHRA and NICE
Using the Integrated Scientific Advice service from the Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE).
Overview
About this service
The Medicines and Healthcare products Regulatory Agency (MHRA) and National Institute for Health and Care Excellence (NICE) deliver the Integrated Scientific Advice service. It provides pharmaceutical companies with coordinated scientific advice on evidence requirements for market authorisation and health technology assessment, through a single, streamlined process. The service is most suitable for products in clinical development and aiming to follow MHRA and NICE aligned pathway timelines.
You can quickly check if your project is eligible for Integrated Scientific Advice by using the check which type of scientific advice you need tool .
Value, benefits and features
The Integrated Scientific Advice service improves and replaces the existing MHRA-NICE joint scientific advice service. It’s designed to support earlier patient access to medicines by helping companies adhere to aligned pathway timelines. By clarifying regulatory and HTA evidence requirements early in the development process, companies can optimise clinical development plans and reduce the risk of unforeseen delays.
Key benefits
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Enhance your credibility with high-quality advice from trusted experts – helpful when preparing to enter other markets.
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Where relevant, MHRA and NICE will provide clarity on how their advice differs from that provided by other global assessment bodies e.g. FDA or EMA.
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Avoid conflicting advice - MHRA and NICE will work collaboratively, yet independently to deliver aligned advice on specific topics where conflict can arise e.g. endpoints and patient populations.
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Discuss your evidence generation plans openly with MHRA and NICE at an integrated scientific advice meeting, prior to receiving a final report
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Gain enhanced clarity and confidence in your product investment – relevant when seeking buy-in from internal stakeholders
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Gain rapid access to health and care system professionals or experts.
Key features
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A single-entry point - making it easier for users to access the service, reducing admin, and freeing up resource.
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A single advice report – receive combined and where relevant, aligned insights in one cohesive document.
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Payment through one route - making it simpler and easier to pay.
How it works
Integrated Scientific Advice gives organisations access to both regulatory and HTA experts. Following an exploratory scientific advice meeting, experts will answer your scientific advice questions and provide aligned advice on how to meet both regulatory and HTA requirements in a single written report.
What advice is available and what types of technologies it is suitable for
You can ask for advice on the design of pivotal studies (including those already in progress, although we recommend requesting as early as possible), generation of real-world evidence and strategic planning for regulatory and HTA requirements. The Integrated Scientific Advice service does not provide joint scientific advice for medical devices. However, NICE offers separate services for medical technology developers and there are separate services for medicine developers wanting only regulatory advice from the MHRA or only HTA advice from NICE
How the Integrated Scientific Advice service works
The request integrated advice step by step shows you the key stages in requesting and receiving advice. Timings for each step of the integrated advice process can be found in the timings section.
Step 1: Check which type of advice you need
Check which type of scientific advice you need to immediately confirm if your project is suitable for Integrated Scientific Advice. This step is important and strongly recommended.
Step 2: Request advice
If Integrated Scientific Advice is appropriate for your project, complete the Request Integrated Scientific Advice form. You’ll be asked to provide details about your project and the advice you’re seeking. After submitting the form, the Integrated Scientific Advice team may contact you for clarifications.
Within 15 working days after requesting advice, you’ll receive a contract and cost estimate. See information on how costs are calculated for the ISA service.
If you accept, the service will agree a date for your integrated advice meeting.
Step 3: Pay for Integrated Scientific Advice
There will be a single fee covering the entirety of the Integrated Scientific Advice service that will be apportioned between NICE and MHRA after you pay.
Payment will be made in two parts. The first payment is 70% of the total fee, and the final 30% payment is made on completion of the project services.
Details of how to pay are included in your contract and cost estimate.
Step 4: Submit your briefing book
Within 20 working days after requesting advice, you’ll need to submit a briefing book. This should include background on your product, development context, and the questions you want to ask.
See additional guidance on preparing the briefing book.
Step 5: Prepare for your meeting
Within 20 working days before your advice meeting, you will submit a short presentation that explains your project and the questions you’d like advice on.
See guidance on how to get the most from the ISA meeting.
Your meeting will then take place. It typically lasts up to 120 minutes, but for complex projects NICE and MRHA may require this to be up to 180mins.
Step 6: Receive your report
Within 45 working days after your advice meeting, you’ll receive a single integrated advice report.
Once you have considered the report findings, you would be invited to ask factual clarification questions, if needed. You may ask up to 3 questions relating to the report recommendations, which will be responded to in writing. These questions should be aimed at clarifying the advice or recommendations included in the report; it will not be possible to answer follow-up questions not included in the scope of the project.
The final payment is made once the project ends.
Timings
Indicative timings
Timelines depend on how quickly you respond to requests and how complete your submitted information is. The table below provides indicative timings for each activity of the Integrated Scientific Advice process. These are intended as guidance and can vary depending on the complexity of the request and the availability of experts.
Figure 1: Indicative timings for each activity of the ISA process
| Approximate day | Activity |
| 0 (start of process) | You check your eligibility and submit the application form (learn more, opens in new tab) |
| 15 | The ISA team provides a contract and estimated cost |
| 20 | You accept the contract and estimated cost (learn more, opens in new tab) |
| 20 | You provide the briefing book (learn more, opens in new tab) |
| 20 | The ISA team asks clarifications on the briefing book (optional) |
| 25 | You answer clarification questions (if needed) |
| 25 | Advice meeting scheduled |
| 35 | The ISA team sends you topics for discussion, to help you shape and improve your advice meeting presentation |
| 50 | You provide your advice meeting presentation (learn more, opens in new tab) |
| 70 | Advice meeting takes place (learn more, opens in new tab) |
| 115 | The ISA team provides the final report (learn more, opens in new tab) |
| 120 | You ask for report clarifications (optional) |
| 140 | The ISA team answers clarifications (if needed) |
Our commitment on timings
Once the request form has been submitted and accepted by the Integrated Scientific Advice team, the integrated advice report will be delivered within 80 working days.
This timeframe assumes that you have responded promptly to requests and provide complete, accurate information. If, for example, your Briefing Book contains different advice questions to previously submitted, we may need to postpone the meeting to account for this new information.
Completing your request
Request form questions
To help you prepare for your request, a (full list of questions asked in the request form)[https://www.gov.uk/government/publications/get-more-help-to-apply-for-medicines-integrated-scientific-advice-isa/all-integrated-scientific-advice-isa-service-application-questions] is available.
Documents you must prepare
Some questions in the request form ask for summaries or supporting documents. You will need to provide a:
- a question list A final, clearly structured document listing the questions you would like advice on. Questions should be numbered and phrased as simply and clearly as possible. To maximise the value of your engagement, we recommend submitting 5 to 9 questions. See guidance on writing good questions for ISA
- summary of previous NICE services used for the product (if applicable): Describe which service(s) you used, the date(s) you used them and the project reference number(s).
- scientific advice reports from other regulatory authorities (if applicable): A brief description of any regulatory advice you’ve received from other authorities. You’ll also need to upload copies of the reports.
- HTA advice reports from other regulatory authorities (if applicable): A brief description of any HTA advice you’ve received from other authorities. You’ll also need to upload copies of the reports.
You do not need to include summaries or uploads of previous MHRA or NICE advice.
Documents you must prepare after the request form
You will need to prepare a:
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briefing book: A document that includes important background on your product, its development context, and the questions you want answered.
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advice meeting presentation: A short set of slides that contains background information on the product. Y
See guidance on preparing these documents
Fees
Fees for Integrated Scientific Advice vary depending on the number and complexity of questions submitted.
There will be a single fee covering the entirety of your Integrated Scientific Advice service that will be apportioned between the two organisations after you pay.
Applicants will receive a cost estimate once their request has been reviewed and accepted.
See information on how costs are calculated for the ISA service.
SME fee reduction
UK-based small and medium-sized enterprises (SMEs) with approved SME status from the MHRA are eligible for a waiver on regulatory scientific advice fees. This waiver is granted under the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 and applies only to the MHRA component of the Integrated Scientific Advice fees.
This waiver means that approved SMEs can access the integrated service at a reduced cost. To benefit from this fee reduction, SMEs must apply for SME status through the MHRA. Once an MHRA SME approval letter is obtained, it must be uploaded when completing full request form.
Preparing for and attending the advice meeting
Ahead of the advice meeting, you will be asked to prepare and provide a set of presentation slides. [See guidance on how prepare these slides](https://www.gov.uk/government/publications/get-more-help-to-apply-for-medicines-integrated-scientific-advice-isa/getting-the-most-from-your-isa-meeting. The Integrated Scientific Advice team will review all materials in advance to ensure they are familiar with the context and content.
During the meeting, company representatives are asked to present the slides to provide relevant context for the questions. The advice team may ask clarification questions to better understand your objectives.
The advice team then discuss key facts, considerations and any regulatory or health technology implications. Company representatives are permitted to ask questions of NICE, MHRA or the experts to clarify points. Meeting advice should be treated as preliminary, and you are encouraged to wait for the report before finalising your development plans.
It is recommended that you take notes during the meeting, as no formal minutes are produced, checked, saved or shared by the Integrated Scientific Advice team.
The report
You will receive a single, integrated report following the meeting, combining advice from both the MHRA and NICE. This will be delivered within 115 working days after your request is submitted. The report begins with a summary of the integrated advice, followed by the answers to your questions, with regulatory advice from the MHRA and HTA advice from NICE
MHRA and NICE will work together to identify areas of alignment between their requirements. NICE will build on the regulatory advice provided by the MHRA, aiming for alignment wherever possible. However, because the two organisations have differing statutory responsibilities (that is, legal duties, remits and decision-making responsibilities), there may be instances where the evidence requirements differ. In such cases, the report will outline the implications of these.
You will have an opportunity to ask about any factual clarifications with the Integrated Scientific Advice team after receiving the report.
Using Integrated Scientific Advice
Scientific advice from the MHRA and NICE is not legally binding and should not be taken as indicative of any future position or decision. It is based on submitted information and current knowledge, and cannot account for future changes in science, regulation or legislation. More information on the limitations of advice is provided in the report. Contact scientific_advice@mhra.gov.uk if you need further detail before submitting a formal request.
Related services
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