Why might I need a Scientific Advice Meeting?
Do you have a questions for the Medicines and Healthcare products Regulatory Agency (MHRA) about the development of your medicine, a Marketing Authorisation Application (MAA) or a variation? Then you may benefit from a scientific advice meeting with the MHRA. Our blog provides an outline of where to start and and how to request a meeting.
You can request a meeting:
- To address a specific scientific issues (e.g. clinical or quality issues)
- Or request a broader scope meeting that is not product specific (e.g. general approach to product development)
You can also choose to ask for a joint scientific advice meeting with the MHRA and National Institute for Healthcare and Excellence (NICE) if this is more appropriate for your product.
How do I request a meeting?
The MHRA have a request form that should be completed to request a scientific advice meeting. A number of supporting documents should be submitted with the request. Fusion Pharma have experience in meetings with the MHRA and can support you to ensure you get the most out of your meeting.
What happens at the meeting?
The meeting is usually scheduled for 90 minutes and currently, due to the COVID-19 situation, meetings are help virtually. The company deliver a short presentation, followed by discussion and questions with the relevant MHRA assessors at the meeting.
After the meeting the MHRA will send the answers to your questions within 30 working days of the meeting.
What is the cost for a meeting?
The fees for a scientific advice meeting can be found here. A waiver from scientific advice fees is available to UK based Small and Medium-Sized Enterprises (SME). You can refer to our blog on SME status for the UK and we can support you gain this.
Our regulatory experts have been involved in many scientific advice meetings and can provide you with in-depth support and guidance. If you would like to discuss scientific advice meetings with Fusion Pharma, please email us at email@example.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.