The UK prime minister Theresa May says that the UK will seek “associate membership” of the European Medicines Agency after Brexit, an announcement that has been welcomed by the UK life sciences industry. However, it remains to be seen what this would entail in terms of UK regulatory input, and whether the EU will agree to negotiating such a status for a departing member state.
The UK government wants to remain part of the European Medicines Agency by negotiating an “associate membership” that would ensure the EMA retained the expertise of the UK regulator, the MHRA, after Brexit.
Disclosing the plan in her Brexit speech in London on March 2, prime minister Theresa May said such an arrangement...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
