Medicines Healthcare Products Regulatory Agency
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Advance notice of changes
From 21 January 2025, the MHRA 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.
Full guidance on this change will be published on 31 January 2025 along with the launch of a series of improvements to our service and guidance. The first improvement is the introduction of a digital application form designed to be simpler, clearer and faster to complete.
Overview
You can ask for scientific advice from the Medicines and Healthcare products Regulatory Agency (MHRA) at any stage of the initial development of your medicine, before you have submitted your application for a marketing authorisation (MA) (product licence) and during the pre-submission period for a variation to an existing MA.
Meetings can also be held with the MHRA to discuss:
- pharmacovigilance
- advertising
- proposals to change labelling or package leaflets
- post-authorisation regulatory advice relating to a product range
You can request a broader scope scientific advice. This would cover broader issues and would not relate to only 1 development programme or product.
You can also have a joint meeting with MHRA and National Institute for Clinical Excellence (NICE).
Scientific advice given by MHRA is not legally binding for any future application of the product discussed, either on the part of MHRA or the company. Advice cant be taken as indicative of any future agreed position.
MHRAs answers are based on the submitted questions and documentation and cannot account for future changes and developments in scientific knowledge or regulatory requirements.
Types of advice
The questions you ask MHRA have to be as precise and clear as possible.
The questions should address specific scientific issues on:
- quality aspects (eg the chemical, pharmaceutical and biological testing necessary to demonstrate the quality of a medicinal product)
- non-clinical aspects (eg the toxicological and pharmacological testing necessary to demonstrate the safety of a medicinal product)
- clinical aspects (eg endpoints, trial duration, target population, choice of comparator etc)
- pharmacovigilance plans and post-authorisation safety study protocols
- an application for a variation or renewal
- advice before publishing advertising for a medicinal product
- changes to labelling of packaging leaflets for medicinal products or a product range
We prefer that the questions are prospective and concern the future development of a medicinal product.
Broader scope meetings
A broader scope meeting is not a product-specific request. Examples include:
- general approaches to product development
- overall product development plans where there are very broad issues that may go beyond what can be discussed at a routine scientific advice meeting
- complex issues of drug/device combination products
- choice (including relative pros and cons) of study endpoints in particular indications
- practical issues of study design, management and analysis
- risk management plans and other post-licensing aspects
- legal reclassification of products from prescription-only medicine (POM) to pharmacy (P) medicine or from P to general sales list (GSL)
We will still need some briefing material for broader scope meetings before the meeting and a general idea of the sorts of issues/questions the sponsor(s) wish to discuss, but the meeting will be much less structured than typical scientific advice or pharmacovigilance advice meetings.
It may be appropriate for the sponsor(s) to give an extended presentation and then there can be a discussion around the issues raised. Meetings will still be planned for up to 90 minutes.
These meetings may include a variety of contributors including external experts and lay or patient representatives. Either or both parties can invite participants. The overall composition of the meeting will be by mutual agreement.
MHRA will charge a fee for broader scope meetings.
As these meetings are more wide-ranging and more speculative, MHRA will not give written advice after the meeting.
These meetings are requested in the same way as standard scientific advice meetings.
Meetings with MHRA and NICE
You can choose to ask for a joint scientific advice meeting with the MHRA and National Institute for Healthcare and Excellence (NICE).
At these meetings you will be able to discuss clinical study design that can satisfy regulatory and NICE requirements. You can also get optional input from the Clinical Practice Research Datalink (CPRD).
Following the meeting, MHRA and NICE will produce separate advice documents to answer the respective questions raised.
Ask for scientific advice
Submit the to scientific_advice@mhra.gov.uk.
On the form you should include:
- therapeutic area
- scope of advice being sought
- number of company staff expected to attend (note that for a meeting with the MHRA Division of Vigilance and Risk Management of Medicines (VRMM) the company attendees should be limited to 4)
- preferred meeting dates and dates to avoid
- a draft list of the proposed questions
A mutually-agreed date will then be set. The final briefing document including all the documents listed below should be delivered to MHRA no less than 10 working days before the date of the meeting.
Documents
You should submit 1 electronic copy of the briefing document, including:
- the final proposed questions together with your position on each question in Word format
- an electronic copy of any presentation to be given at the meeting
- any appendices
- labelling and leaflet artwork examples if the meeting is about changes to labelling and leaflets for a product or range of products
The appendices, if relevant, can include:
- background information
- information relating to the questions (eg relevant study protocols)
- content of previous scientific advice received (MHRA relevant international authorities)
- relevant guidelines
The appendices should be limited to essential information. Extensive information, in excess of that specified in relevant summaries in the Common Technical Document, should not be included.
We will tell you how many paper copies of the briefing document and any presentations should be submitted.