Sarah Wollaston, chair of the Commons health committee, has asked the government to clarify its intentions for the relationship between the UK MHRA and the EMA during and after any Brexit transition period.
The chair of the UK House of Commons health and social care committee has called on the health secretary, Jeremy Hunt, to explain the government’s expectations for the relationship between the UK regulatory agency, the MHRA, and the European Medicines Agency after Brexit, including details of any specific EMA meetings the MHRA might be invited to attend.
MP Sarah Wollaston wrote to Hunt after the March 19 publication of the draft Brexit withdrawal agreement – including the...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
