EMA To Speed Up Orphan Approvals By Closing Gap Between CHMP, COMP Opinions
Executive Summary
The European Medicines Agency has initiated steps to ensure that the opinions issued by its human medicines evaluation committee and the orphan drugs committee for certain types of innovative orphan drugs reach the European Commission at around the same time. While the move is expected to facilitate an earlier decision on the marketing authorization applications of such products, industry says it does not go far enough.
You may also be interested in...
Global Pharma Guidance Tracker – March 2024
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
EU Regulators Explain How To Ensure Transitioned Trials Align With CTR
Members of the EU’s Clinical Trials Coordination Group have developed harmonized requirements for updating trials that are transitioned to the Clinical Trials Information System based on a minimum set of documents.
Global Medtech Guidance Tracker: March 2024
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-nine documents have been posted on the tracker since its last update.