Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
The European Medicines Agency (EMA) on Tuesday released its 2017 work plan for good clinical practice (GCP) inspections, which involves collaborating with the US Food and Drug Administration (FDA) to limit duplicative inspections.
Among other expectations for the coming year, the EMA’s GCP Inspectors Working Group will develop new and revised guidelines on the redaction of inspection reports to protect personal data and commercially confidential information, as well as collaborations with member states on other inspections, both of which align with the implementation of the new Clinical Trials Regulation.
Revisions on GCP guidelines for advanced therapy medicinal products and recommendations on the qualifications of inspectors verifying trial compliance with GCPs will be finalized in 2017.
EMA says the following objectives will drive its agenda in the coming year:
“In order to save resources, duplication of inspections should be avoided and increased inspection coverage will be ensured for MAA submitted to both, the Agency and the US FDA,” the work plan says.
Back in 2009, EMA and FDA launched its GCP initiative, which has expanded to include Japan’s Pharmaceuticals and Medical Devices Agency, which will continue in 2017 alongside the more recently established joint EMA-FDA generic drug application inspections initiative from 2013.
EMA will also look to assist other countries in the development of GCP inspection roles, including Albania, the former Yugoslav Republic of Macedonia, Montenegro, Serbia, Turkey, Bosnia and Herzegovina and Kosovo.
Work plan for GCP Inspectors Working Group for 2017
Tags: GCP guidelines, GCP inspections, trial site inspections