UK MHRA REVISES APPROACH TO SCIENTIFIC ADVICE MEETINGS

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has announced changes to its system for providing scientific and regulatory advice to clinical trial sponsors.

As an initiative of the Ministerial Industry Strategy Group Long Term Leadership Strategy Regulatory Workstream, discussion meetings may now be held between the MHRA and sponsors on less specific topics and on topics where no definitive answers may be possible. Examples of what might be discussed 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 of study endpoints in particular indications; practical issues of study design; management and analysis; risk management plans and other postmarketing aspects.

The meetings will be much less structured than current scientific advice or pharmacovigilance advice meetings. It may be appropriate for the sponsor to make an extended presentation, and then there can be discussion around the issues raised. Meetings will still be planned to last up to 90 minutes. Given the potentially wide-ranging and perhaps more speculative discussion, the MHRA will not give written advice for these meetings.