International collaboration to enhance global drug quality and safety
The U.S. Food and Drug Administration, together with its European and Australian counterparts, recently released the results of pilot programs focused on increasing international regulatory collaboration in order to enhance drug quality and safety globally.
The report on the Good Clinical Practice (GCP) initiative details the success of information sharing and collaboration on inspections relating to clinical trials. The FDA and EMA exchanged more than 250 documents relating to 54 different medicines and, in conjunction with the GCP inspectors of the European Union (EU) member states, organized 13 collaborative inspections of clinical trials.
This project lays the foundation for a more efficient use of limited resources, greater protection of participants in clinical trials and better ensures the integrity of data submitted as the basis for drug approvals.
The second pilot program concerned information sharing and collaboration on active pharmaceutical ingredient 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.
These pilot programs are part of the FDA's global strategy to ensure the safety and quality of imported products.
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