Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he has made an assessment of the adequacy of the Medicines and Healthcare products Regulatory Agency on the adequacy of response times to requests for further information on clinical trials.

Before December 2021, applicants were required to respond to all requests from the Medicines and Healthcare products Regulatory Agency for further information (also known as ‘grounds for non-acceptance’) within 14 days. However, since December 2021, applicants have had the flexibility to request additional time to respond to requests for further information, as required, by contacting the Clinical Trials Helpline.

Furthermore, as stated in the Government response to the Consultation on legislative proposals for clinical trials (published 21 March 2023), we will introduce a 60-day timeframe (with flexible extension) to respond to any requests for further information. This flexibility will enable sponsors to prepare robust responses and interact with assessors to satisfy the regulators and avoid application rejections. It is important to note that the 60-day proposal is a maximum timeframe, so the sponsor could respond as quickly as they would like up to this limit.