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Overview

You can ask the MHRA for scientific advice at any stage of your medicines 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 moreinformation 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 medicines 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 medicines 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 for off-patent medicines

• 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:

• general approaches to product development

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

• discussion of complex drug/device combination products

• choosing study endpoints, including pros and cons

• practical issues of study design, management and analysis

• risk management plans and other post-licensing topics

• 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 NICEs 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

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