FDA Sheds Light on International GCP Inspection Collaborations
The FDA is putting new emphasis on its collaboration with multiple international regulators to bolster oversight of GCP and data integrity in clinical trials.
As part of this increased emphasis, the agency launched a new webpage last week with updates on the Center for Drug Evaluation and Research (CDER)’s work with the European Medicines Agency (EMA), the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Health Canada and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) to conduct joint inspections and share lessons learned with stakeholders.
Specifically, the page includes a section on CDER’s international GCP joint workshops and a link to receive updates on newly announced conferences, as well as a section on publications, articles and reports and information the agency shares with its regulatory partners.
Access the page here: https://bit.ly/3xQNcl8.