Revised Guide Clarifies Scope Of EMA Policy On Proactive Publication Of Clinical Data
Executive Summary
The European Medicines Agency has issued revised guidance to further clarify what information in regulatory submissions is covered by its policy on the proactive publication of clinical data. The updated guideline also addresses certain procedural issues to help companies submit proposed redactions.
You may also be interested in...
It’s Started: EMA Proactively Publishes Clinical Data On New Drugs
The European Medicines Agency has delivered on its promise to grant public access to clinical reports that form the basis of its recommendations to the European Commission on whether or not a medicine should be authorized for use in the EU.
Global Medtech Guidance Tracker: January 2023
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-eight documents have been posted on the tracker since its last update.
EU Regulators May Check Redactions In CTIS Documents To Boost Trial Transparency
A new EU guideline addresses numerous questions raised by study sponsors on processes for protecting commercial and personal data while using the Clinical Trials Information System.