Pilot programmes launched to increase collaboration of inspections between the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Australia’s Therapeutic Goods Administration (TGA) have been deemed successful.
The FDA and EMA concluded a programme that handled good clinical practice, with the two agencies exchanging documents relating to 54 medicines before organising 13 inspections of clinical trials.
The second pilot programme involved information sharing and collaboration regarding active pharmaceutical ingredient inspections, conducted over a two-year period by the FDA, EMA and TGA as well as the European Directorate for the Quality of Medicines and Healthcare.
The pilot programmes have laid the groundwork for further collaboration between the agencies, including a more efficient use of resources, improved inspectional coverage and further understanding of inspection procedures.
