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.
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.”
Among its plans are new maximum timelines for the combined review of trial applications, more flexibility on requests for information...
<p>Executive Summary</p> <p>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.</p>
As the reform of the EU pharmaceutical legislation progresses through the legislative process, the Pinks Sheet offers an infographic highlighting some of the key changes being proposed that will reshape the way drug companies run their business.
<p>Executive Summary<p> <p>The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, incl/ding Ixchiq, Valneva's chikungunya virus vaccine</p>
A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.
With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be implemented.
