EMA, FDA Get Together On Drugs Eligible For PRIME And Breakthrough Designation
This article was originally published in SRA
Executive Summary
The European Medicines Agency and the US Food and Drug Administration are looking at ways to exchange notes on drugs that become eligible for their respective schemes on speeding access to new innovative medicines ie, Priority Medicines (PRIME) in the EU and breakthrough therapy designation in the US.
You may also be interested in...
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.
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.