A report from the EU medicines regulatory network looks at what was done well in the response to the COVID-19 pandemic, and what needs to be improved if we are to be better prepared next time.
Larger, more methodologically sound clinical trials and an infrastructure for producing real-world evidence will be two of the key requisites for regulatory decision-making in the event of a future health emergency, says a new report from the European Medicines Agency and the Heads of Medicines Agencies.
Regulators will also need enough reserve resource capacity to support crisis-related work such as accelerated reviews for pandemic products, and...
<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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
