EMA launch of International Sterile Medicines Inspection Pilot Program

European Medicines Agency (EMA) launched a 2-year pilot that would allow regulators all across the world to share information on good manufacturing practice (GMP) inspections of sterile medicines manufacturing sites.

Specifically, the program will allow information sharing from GMP inspections of manufacturers located in countries that are not participating in the pilot and to promote organize joint inspections.

Lasting a minimum of 2 years, this pilot will involve:

  • EMA
  • US FDA
  • UK’s MHRA
  • France’s ANSM
  • Australia’s TGA
  • Health Canada
  • Japan’s PMDA
  • World Health Organisation

Throughout the program, participants will coordinate and share their inspection plans alongside other participating authorities. This effort will see inspections being done according to predefined GMP requirements, encouraging the coordination of joint inspections rather than sole or concurrent inspections.

This pilot would be applicable to human drugs and certain therapeutic biologics, such as monoclonal antibodies and recombinant proteins, excluding vaccines, cell and gene therapies and plasma-derived products.