Medicines: get scientific advice from MHRA
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Advance notice of changes
From 21 January 2025 we will review all new requests for scientific advice meetings against whether the requirements can be addressed with existing guidance, written advice or a scientific advice meeting.
For a temporary period, you should therefore expect that an increased number of requests will be progressed as written-only advice from our experienced MHRA specialists.
From 1 February 2025, all new requests must pay for their advice no later than 3 weeks before any meeting date. To assist you with this, we will send you personalised links to pay through Gov Pay when we confirm the meeting.
Overview
You can ask the MHRA for scientific advice at any stage of your medicine’s development or regulation.
You can ask for written advice only, or a meeting. After some meetings the MHRA will provide a written summary of advice (see the Types of meeting section for more information on written advice provided after meetings).
You can ask for specific advice on a single development programme or product lifecycle, or broader advice not limited to a single development program or product lifecycle.
You can ask for a meeting with the MHRA only, or a joint meeting with the MHRA and the National Institute for Health and Care Excellence (NICE).
The MHRA advice is based on the questions and documents you provide. The advice cannot account for future changes in scientific knowledge or regulatory requirements.
Scientific advice from the MHRA is not legally binding for future applications of the discussed product. You should not consider the advice as an indication of a future agreed position.
Process and timelines
After you have asked for advice, the MHRA will acknowledge your request within 10 working days.
The time it takes to get written advice or advice via a meeting depends on the subject matter and expertise needed. We strongly encourage early planning and sending of advice requests.
For meetings, you must send your final questions list and briefing document to the MHRA at least 3 weeks before the meeting date. If you do not do this, the meeting will be delayed.
After some meetings the MHRA will provide a written summary of advice (see the Types of meeting section for more information on written advice provided after meetings). If offered, the MHRA will send this final advice letter within 6 weeks of the meeting taking place.
MHRA expertise on offer
The MHRA has extensive experience and expertise to answer questions on your medicine’s lifecycle. To get the best advice and access the most relevant experts, the questions you send in advance should be clear and specific.
For advice on writing questions, go to the Supporting document guidance section.
Types of meeting
Scientific advice meeting
The MHRA primary advice service is targeted scientific advice for individual products.
While we offer advice at any stage of your medicine’s lifecycle, we particularly encourage organisations to request advice at the following points:
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first in human studies: get guidance on translating safety and non-clinical data into key clinical trial designs
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design of pivotal clinical trials: receive advice from clinical trials and marketing authorisation assessors on designing pivotal studies, ensuring appropriate safety studies and clinical endpoints are chosen to determine safety and efficacy
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chemistry, manufacturing and control (CMC)/biological process requirements for marketing authorisation: get advice from quality and pharmaceutical assessment teams on chemical and biological processes for new actives, pharmaceutical formulations, and stability protocols
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design of bioequivalence studies for generic medicines: identify the best approaches to bioequivalence studies for off-patent medicines
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reclassification and repurposing programmes: receive advice on clinical and regulatory aspects to ensure high-quality applications through these programmes
The attendees and format of these meetings can vary but will be mutually agreed in advance.
These meeting are typically well structured. Meetings last up to 90 minutes.
We provide written advice after the meeting.
Broader scope advice meeting
The MHRA accepts requests for advice across the entire medicine lifecycle, focusing on our areas of expertise. Broader scope advice meetings are usually not about a specific product. Examples of meetings include:
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general approaches to product development
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overall product development plans with complexities that go beyond routine scientific advice meetings
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discussion of complex drug/device combination products
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choosing study endpoints, including pros and cons
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practical issues of study design, management and analysis
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risk management plans and other post-licensing topics
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legal reclassification of products from prescription-only medicine (POM) to pharmacy (P) medicine or from P to general sales list (GSL)
The attendees and format of these meetings can vary but will be mutually agreed in advance. They can include various contributors such as external experts and patient representatives. Both parties can invite participants. Some meetings work best when the sponsor gives a presentation followed by a discussion by the wider group.
These meeting are typically less structured than typical scientific advice or pharmacovigilance meetings. Meetings last up to 90 minutes.
Since these meetings are wide-ranging and speculative, the MHRA does not provide written advice afterwards.
Joint scientific advice with the MHRA and NICE
The MHRA can also participate in joint scientific advice meetings with the MHRA and the National Institute for Health and Care Excellence (NICE).
In these meetings, you can discuss clinical study designs that meet both regulatory and NICE’s health technology assessment requirements. You can also get optional input from the MHRA Clinical Practice Research Datalink (CPRD).
The attendees and format of these meetings can vary but will be mutually agreed in advance. Meetings last up to 3 hours.
After the meeting, the MHRA and NICE will each produce separate advice documents to answer the respective questions raised.
Ask for scientific advice
The Ask for scientific advice form will guide you through the steps to request a meeting or written advice.
Use this form for any type of advice or meeting request. The first page of the form explains what you will need to prepare before you start.
After the form is completed
The MHRA will aim to acknowledge your request within 10 working days.
If you requested a meeting, a mutually agreed date will be set.
You must deliver the requested documentation, including your briefing document and final questions list, to the MHRA at least 3 weeks before the meeting date.
After some meetings the MHRA will provide a written summary of advice (see the Types of meeting section for more information on written advice provided after meetings). If written advice is available, the MHRA will send this within 6 weeks of the meeting taking place.
Supporting document guidance
The Ask for scientific advice form will prompt you to upload supporting documents. If it is not possible to submit these documents at the time of requesting advice, you can send them afterwards by email. You must provide documents at least 3 weeks before a meeting.
Briefing document
You need to send the MHRA a briefing document, or small number of briefing documents relating to your questions before we can give advice.
Briefing materials should be collated into a single or small number of documents. You should submit electronic copies, and include:
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any presentation that will be given at a scientific advice meeting
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labelling and leaflet artwork examples, if the meeting is about changes to labelling and leaflets for a product or range of products
To provide further relevant context to your questions, you can also upload appendices as part of the briefing documents. Appendices should be limited to essential information only, but can include:
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relevant background information
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relevant information to your questions (for example, relevant study protocols)
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previous scientific advice received from the MHRA or other relevant international authorities
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relevant guidelines
Questions you need advice on
You need to send the MHRA a list of questions you need advice on before we can give advice.
Your final questions list should focus on the future development, variation or risk management plan for your medicinal product. Questions should focus on specific scientific issues such as:
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quality aspects, for example, chemical, pharmaceutical and biological testing to show the quality of a medicinal product
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non-clinical aspects, for example, toxicological and pharmacological testing to show the safety of a medicinal product
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clinical aspects, for example, endpoints, trial duration, target population, choice of comparator
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pharmacovigilance plans and post-authorisation safety study protocols
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applications for variations or renewals
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advice before publishing advertisements for a medicinal product
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changes to labelling or packaging leaflets for medicinal products or a product range
Before the meeting
If you have requested a meeting, you must send your briefing document and final questions list to the MHRA at least 3 weeks before the meeting date. If you do not do this, the meeting will be delayed.
MHRA staff will review your documents and may contact you with provisional advice or further questions.
At the meeting
Successful meetings often start with a short presentation (10 to 15 minutes) by the person or organisation asking for advice. This presentation often delivers an overview of the issues or controversies surrounding their questions.
If possible, you should include the information contained in your presentation as part of the briefing documents provided to the MHRA in advance.
Meeting process
The meeting may be recorded to help produce a written advice letter, which we provide for some types of meeting (see the Types of meeting section for more information on written advice provided after meetings). Any recordings will be for MHRA use only; we will delete them after we provide the written scientific advice.
You should take notes during the meeting and provide them to the MHRA no later than 15 working days after the meeting.
After the meeting
You should send us your meeting notes within 15 working days of the meeting taking place. Unless you have requested broader scope advice, the MHRA will send a scientific advice letter with answers to your questions (see the Types of meeting section for more information on written advice provided after meetings). We will send this letter within 6 weeks of the meeting.
If you need clarification on the advice provided, you can ask us by email or an online meeting.
When asking for clarifications you should not expand the scope of the original advice sought or ask new questions based on the advice given. If you do, this additional advice will be charged at the same rate as the original meeting.
Limitations of MHRA advice
The MHRA works hard to provide useful, accurate and expert advice.
However, the advice provided is given without prejudice. This means it does not override any laws about the details and documents needed for a marketing authorisation (or other) application. It also does not affect any intellectual property rights that belong to third parties.
Fees
Paying fees
When your advice fee is confirmed by the MHRA, you will receive a link to pay.
You need to pay at least 3 weeks before your meeting date, or your meeting may be delayed.
Fee exemptions for UK-based SMEs
UK-based small and medium-sized enterprises (SMEs) with approved SME status do not have to pay for scientific advice. This is according to the Human Medicines (Amendment etc.) (EU Exit) Regulations 2020.
SMEs must apply for SME status from the MHRA to be eligible for this fee waiver.
Contact
Updates to this page
Published 29 December 2014Last updated 31 January 2025 + show all updates
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Updated guidance on the types of advice, expertise and expected customer touchpoints, and to highlight the new requirement for paying fee before meeting. Replaced downloadable form with an interactive form.
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Temporary changes to the MHRA scientific advice service and future improvement such as a digital application form.
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Updated contact email address
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Made an edit to the text in the grey box
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Updated request for scientific advice form
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Updated a contact email address
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New form for request for scientific advice added and fees for scientific advice have been updated.
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Updated to reflect changes to regulations following Brexit transition.
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Added a case study detailing a successful joint scientific advice meeting that the MHRA and NICE had with the University of Birmingham.
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Added CTA to top of page
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Updated contact details
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Link to CPRD added.
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First published.