International Regulators Launch Pilot for Sterile Drugmaker Inspections

The FDA, EMA and other regulators have kicked off a pilot program for working together on GMP inspections of sterile medicine manufacturers abroad.

The pilot, which also involves Australia’s TGA, Health Canada, Japan’s PMDA and the WHO, will last a minimum of two years. The project is geared towards sharing information on GMP inspections and partnering on inspections for relevant facilities.

The program aims to monitor sterile drugs used by humans, as well as certain therapeutic biotech products, including monoclonal antibodies and recombinant proteins. The program will not cover vaccines, cell and gene therapies, and plasma-derived pharmaceuticals.