EMA Launches Inspection Pilot Program

December 18, 2019

The European Medicines Agency and its European partners have launched a pilot program for cooperation in the inspection of facilities that manufacture sterile drug products.

On Dec. 17, 2019, the European Medicines Agency (EMA) announced it was launching a pilot program to increase the inspection of facilities that manufacture sterile pharmaceuticals with its international partners. The pilot program will last for at least two years. EMA has a similar collaboration for the inspection of API facilities.

The collaboration between EMA, EU national authorities (France and the United Kingdom), the US FDA, Australia's Therapeutic Goods Administration (TGA), Health Canada, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the World Health Organization (WHO) will allow the various agencies to share information on good manufacturing practice (GMP) inspections of companies that manufacture sterile drugs and who are located outside the participating countries. The collaboration will also allow the countries to organize joint inspections for manufacturing sites of common interest.

“International collaboration in inspections has demonstrated its benefits in improving oversight of manufacturers and making best use of inspection resources worldwide, through mutual reliance between participating regulatory bodies, the reduction of duplication of inspections and the increase in the coverage of sites inspected worldwide,” EMA stated in a press release.

Source: EMA