The UK pharmaceutical industry is concerned about potential barriers to trade that might arise with the EU post-Brexit, especially if co-operation mechanisms such as mutual recognition agreements are not in place by the time the UK leaves. API manufacturers have specific worries, but there won’t be answers for some time.
Active pharmaceutical ingredient (API) manufacturers in the UK seeking to export to the EU post-Brexit could in theory be required in advance to have written confirmation from the country’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), that they comply with EU good manufacturing practices (GMP).
Getting on the EU’s so-called “white list” of accredited countries whose GMP framework is considered equivalent to that of 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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
