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Overview

Scientific Advice is an advisory function from the MHRA to aid product development.

You can ask the MHRA for scientific advice at any stage of your medicine’s development or regulatory lifecycle.ÌýYou 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.Ìý 

Advice is requested through the online form (see the Ask for scientific advice). You can request written advice only, or a meeting followed by a written summary of advice (see the Types of meeting section for more information on written advice provided after meetings).ÌýIf written advice is requested, the MHRA will decide if it is appropriate to do so or whether a meeting is required.

You can ask for a meeting with the MHRA only through the link , or a joint meeting with the MHRA and the National Institute for Health and Care Excellence (NICE) (see the Integrated Scientific Advice section).Ìý

°Õ³ó±ðÌý advice provided by the MHRA will be based on the questions and documents you provide (see Supporting Documents Guidance). The advice cannot account for future changes in scientific knowledge or regulatory requirements.Ìý

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.Ìý

Process and timelines 

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 with a final list of questions and briefing document(s) at the point of submission.Ìý

For requests, you must send your final questions list and briefing document (s) should be provided at the point of submission to the MHRA.Ìý

A contact person from the MHRA will offer a meeting date (or for written advice, provide a timeline of when the advice letter will be sent) within 10 working days of the acknowledgment of the submission, provided the request is in scope.

After most meetings the MHRA will provide a written summary of advice (see the Types of meeting section). If offered, the MHRA will send this final advice letter within 30 working days of the meeting taking place.Ìý

MHRA expertise on offer  

°Õ³ó±ðÌýMHRA 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.Ìý

For advice on writing questions, go to the Supporting document guidance section.Ìý 

Types of meeting 

Scientific advice meeting 

°Õ³ó±ðÌýMHRA primary advice service is targeted scientific advice for individual products.Ìý

While we offer advice at any stage of your medicine’s lifecycle, we particularly encourage organisations to request advice at the following points:  

• first in human studies: get guidance on translating safety and non-clinical data into key clinical trial designs 
• 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 
• 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 
• design of bioequivalence studies for generic medicines: identify the best approaches to bioequivalence studies
• repurposing programmes: receive advice on clinical and regulatory aspects to ensure high-quality applications through these programmes 
• reclassification of products from prescription-only medicine (POM) to pharmacy (P) medicine or from P to general sales list (GSL) 
• Patient Information and Quality unit:  pack design and risk-minimisation measures to support the safe and effective use of a medicine
• pharmacovigilance expectations and public‑health and risk‑minimisation considerations.

Meetings are normally conducted by teleconference, with joining instructions provided beforehand. Recording is not permitted. In-person meetings will only be arranged where agreed in advance by the Chair.

The attendees and format of these meetings can vary but will be mutually agreed in advance.Ìý 

These meeting are typically well structured. Meetings last up to 90 minutes.Ìý

We provide written advice after the meeting.Ìý

Broader scope advice meeting 

Broader scope advice meetings are usually not about a specific product. Examples of meetings include: 

• general approaches to product development 
• overall product development plans with complexities that go beyond routine scientific advice meetings 

The attendees and format of these meetings can vary but will be mutually agreed in advance. Some meetings work best when the organisation gives a presentation followed by a discussion by the wider group.Ìý 

These meeting are typically less structured than typical scientific advice or pharmacovigilance meetings. Meetings last up to 90 minutes.Ìý

Since these meetings are wide-ranging and speculative, the MHRA does not provide written advice afterwards.ÌýMinutes of the meetings or notes can be provided from the company, and the assessment team will check that the discussion has not been misinterpreted.

Joint scientific advice with the MHRA and NICE  

You can also get advice from the MHRA and NICE together.

See detailed guidance on the Integrated Scientific Advice service.Ìý

Access the

Learn more about how the MHRA and National Institute for Health and Care Excellence (NICE) are collaborating to align decisions to get medicines to patients 3-6 months sooner. Our ambition is to achieve same time publication for marketing authorisation and NICE guidance, supported by information sharing, the integrated scientific advice service and aligned pathway.

Real-World Data (RWD) and Real-World Evidence (RWE) advice

The MHRA offers scientific advice on the use of real-world data (RWD) and real-world evidence (RWE) in medicines development, authorisation and post-authorisation evidence generation. Advice on RWD and RWE may be sought through MHRA Scientific Advice or through Integrated Scientific Advice with the MHRA and NICE.

Sponsors may also be interested in the MHRA–NICE Real-World Evidence Scientific Dialogue, which holds precompetitive, ‘safe harbour’ workshops to discuss RWE study designs, data sources and analytical approaches and to promote shared understanding of regulatory and health technology assessment evidence needs.

Devices, in vitro diagnostic devices and Clinical Investigations regulatory advice meetings

The MHRA runs advisory services for medical devices and in vitro diagnostic devices and clinical investigations.

Regulatory advice

For questions regarding reference and comparator products, contact Information Services at informationservices@mhra.gov.uk.

For questions regarding the legal basis of your submission, route of submission (e.g. national procedures or International Recognition Procedure), or other regulatory matters, contact the Regulatory Information Service (RIS) team at ris.na@mhra.gov.uk.

If these questions are combined with scientific questions (such as bioequivalence study design), contact Scientific Advice at scientific_advice@mhra.gov.uk.

Ask for scientific advice  

°Õ³ó±ðÌý 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.Ìý

NOTE: °Õ³ó±ðÌýMHRA will not be able to process receipt of your request until we receive a complete list of Questions to be asked.

After the form is completed 

If you requested a meeting, a mutually agreed date will be set..

Minor adjustments are allowed to the briefing document(s) to the MHRA with approval from the Head of Team.  

If there are any significant changes to the questions or the scope of the advice, then the meeting will be rescheduled and will be treated as a new request. This will result in extended timeframes for providing the advice.

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 30 working days of the meeting taking place.Ìý

Supporting document guidance 

You should upload supporting documents. To effectively triage the request to the correct team the briefing document(s) should be provided at the point of submission.

Briefing document(s) 

You need to send the MHRA a , or small number of briefing documents relating to your questions before we can give advice.Ìý 

For each question included in the Scientific Advice request, the organisation is requested to provide a clear and well supported position within the briefing document. The position should include a concise rationale, the scientific justification, and the proposed approach, ensuring the MHRA can understand the reasoning behind the development strategy.

The MHRA will review the positions and provide comments on the acceptability of the proposals.

Organisations are strongly encouraged to consult relevant published scientific and regulatory guidance issued by the MHRA, as well as international guidance from recognised regulatory authorities. This will help ensure that the positions set out in the briefing document are aligned with current regulatory expectations and comply with applicable requirements. Briefing materials should be collated into a single or small number of documents. You should submit electronic copies, and include:  

• any presentation that will be given at a scientific advice meeting  
• 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: 

• relevant background information  
• relevant information to your questions (for example, relevant study protocols)  
• previous scientific advice received from the MHRA or other relevant international authorities 
• 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.Ìý 

Your list of questions should focus on the future development, variation or risk management plan for your medicinal product. Questions should focus on specific scientific issues such as: 

• quality aspects, for example, chemical, pharmaceutical and biological testing to show the quality of a medicinal product 
• non-clinical aspects, for example, toxicological and pharmacological testing to show the safety of a medicinal product 
• clinical aspects, for example, endpoints, trial duration, target population, choice of comparator 
• statistical aspects, for example, analysis methods, study populations, methods for handling of missing data, relevant sensitivity analyses, reducing basis
• drug-device combinations
• pharmacovigilance plans and post-authorisation safety study protocols 
• applications for variations or renewals 
• changes to labelling or packaging leaflets for medicinal products or a product range 

Before the meeting 

MHRA staff will review your documents and may contact you with provisional advice or further questions.Ìý

At the meeting  

Successful meetings often start with a short presentation (10 to 15 minutes) by the person or organisation asking for advice. . You can explain your product in more detail and the scope of the advice. This presentation often delivers an overview of the issues or controversies surrounding their questions.Ìý 

You should include the information contained in your presentation as part of the briefing documents provided to the MHRA in advance.Ìý

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.Ìý

You should take notes during the meeting and provide them to the MHRA no later than 5 working days after the meeting.ÌýThe meeting should not be recorded by the company.

After the meeting  

You should send us your meeting notes within 5 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 30 working days of the meeting.Ìý 

If you need clarification on the advice provided, you can ask us by email or an online meeting.Ìý 

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.Ìý

Limitations of MHRA advice  

°Õ³ó±ðÌýMHRA works hard to provide useful, accurate and expert advice.Ìý

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.Ìý

Performance metrics

Performance data

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Fees for scientific advice.  

For questions related to the medicines, the fee is set based on the number of disciplines involved, the number of questions, the topics, and complexity of the questions.

Paying fees 

When your advice fee is confirmed by the MHRA, you will receive a link to pay.Ìý 

You need to pay at least 15 working days before your meeting date, or your meeting may be delayed.Ìý

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.Ìý

³§²Ñ·¡²õÌý³¾³Ü²õ³ÙÌýapply for SME status from the MHRA to be eligible for this fee waiver.Ìý

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scientific_advice@mhra.gov.uk