Clinical Trials: Standards
(asked on 21st May 2025) - View Source
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, what steps the MHRA is taking to improve (a) transparency and (b) predictability for companies seeking UK Market Authorisations.
The Medicines and Healthcare products Regulatory Agency (MHRA) has taken significant steps to improve transparency and predictability for companies seeking United Kingdom market authorisations. This includes clearer guidance, enhanced pre-submission scientific advice, published performance standards, and expanded use of international reliance frameworks.
The agency’s 2024/25 Business Plan gave a commitment to its focus being the optimisation of its service delivery for customers. It introduced key performance indicators (KPIs) and a corporate objective to enhance the transparency and accessibility of our performance data. The agency provides its performance data for every month and year to date performance for each KPI on its GOV.UK website. Its aim is to help applicants with decision making, based on its performance data, and to ensure greater accountability for its service delivery. The business plan is available at the following link:
The RegulatoryConnect portal will provide greater transparency and visibility for regulatory assessments to industry. The functionality will let industry users log in using existing MHRA submission credentials and access RegulatoryConnect, where they will be able to: use the Applications page to track the status of an application and see which stage it is at; and use the Current Granted View page to view live authorisation details, including status, key data and documents held against existing licences.