Two pilot programmes of collaboration on inspections between the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Australia’s Therapeutic Goods Administration (TGA) and other European agencies have concluded successfully, the agencies report.
One of the two inspection pilot programmes dealt with good clinical practice (GCP) and was conducted between the FDA and EMA. The two agencies exchanged more than 250 documents relating to 54 different medicines and, in conjunction with the GCP inspectors of the European Union (EU) member states, organised 13 collaborative inspections of clinical trials.
This project will lay the foundation for a more efficient use of limited resources, improved inspectional coverage and better understanding of each agency’s inspection procedures, say the FDA and EMA. It has also demonstrated how the agencies can work together to improve the protection of participants in clinical trials and better ensure the integrity of data submitted as the basis for drug approvals, they add.
The other pilot programme concerned information-sharing and collaboration on active pharmaceutical ingredient (API) inspections. It was conducted over a 24-month period by the EMA, FDA and Australia’s TGA, plus France, Germany, Ireland, Italy, the UK and the European Directorate for the Quality of Medicines and HealthCare (EDQM). The participants shared their surveillance lists and found 97 sites common to all three regions, resulting in the exchange of nearly 100 inspection reports and in nine joint inspections.
The FDA says it has used these reports to inform decisions, such as whether to postpone or expedite its own inspection, and that it has also prohibited imports into the US of a firm’s products based on the negative findings from a European inspection.
The information-sharing and collaborative inspections were important milestones in establishing a sense of mutual trust and common purchase among the drug regulatory agencies involved, and are major stepping-stones toward further global regulatory collaboration, says the US agency. “It is imperative that FDA work closely with its counterparts in order to ensure the safety and quality of products and the integrity of clinical trials – we cannot do it alone,” added Deborah Autor, the FDA’s deputy commissioner for global regulatory operations and policy.
The US agency recently unveiled a new strategy aimed at meeting the challenges posed by rapidly-rising imports of FDA-regulated products and a complex global supply chain. The strategy calls on the FDA to transform the way it conducts business, build on its ongoing collaborations with its regulatory partners around the world and act globally to promote and protect the health of US consumers.
Describing the experience of both pilots as “positive,” the participating agencies say they have agreed to continue with their collaboration.
