The UK Medicines and Healthcare products Regulatory Agency has launched a public consultation to elicit stakeholder input on its plans for a post-Brexit revamp of the clinical trial regulations designed to make the UK “the leading global center for innovative research design and delivery.”
UK Kicks Off Landmark Overhaul Of Clinical Trial Framework
Changes Affect Processes, Requirements & Timelines
The UK regulatory agency, the MHRA, is planning to establish a “world-class sovereign regulatory environment” for clinical trials to support the development of new innovative medicines. In the first of two articles, we look at the MHRA’s proposals to slim down trial approval processes, lighten the safety reporting burden, and introduce greater transparency of trial registration and results.
More from Europe
More from Geography
• By
The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.
• By
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
• By
US CDC’s Advisory Committee on Immunization Practices voted for harmonized meningococcal vaccine recommendations, while hearing updates about Sanofi’s pending supplemental MedQuadfi indication, AstraZeneca’s FluMist self-administration launch plans, and Lyme disease