The EU is taking steps to establish a more consistent and standardized approach to the quality of data used in medicines regulation to support benefit-risk decisions.
Regulators in the EU are inviting feedback on a draft framework that seeks to define quality requirements for all types of data used in regulatory decision-making. When finalized, it can help drug companies and other stakeholders in selecting appropriate current and novel data sources for their studies.
The data quality framework (DQF) was developed by the European Medicines Agency, the EU Heads of Medicines Agencies and 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With the deadline for comments on the US FDA’s draft guidance less than a month away, the Pink Sheet offers an infographic outlining what the agency is expecting in diversity action plans and when that might be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.
