An unprecedented proposal by the International Council for Harmonisation that would let member states selectively adopt certain parts of one of its quality guidelines has drawn criticism from EU pharmaceutical industry associations.
A proposal by the International Council for Harmonisation that would allow ICH member states to "selectively adopt" certain parts of its draft Q12 guideline on managing post-approval changes has drawn strong criticism from EU pharmaceutical companies.
The ICH introduced this unprecedent proposal in the draft Q12 guideline after it became clear that some of the regulatory...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
