EMA Launches Joint Inspection Program for Sterile Drugs

By Emily Forster -

January 16, 2020

The European Medicines Agency (EMA) and its European and international partners have launched a pilot program to increase their cooperation in the inspection of manufacturers of sterile medicines for human use. This new initiative is built on the experience gained from a similar collaboration, the international active pharmaceutical ingredients (APIs) inspection program, which facilitates sharing of information on inspection planning and outcomes, and organization of joint inspections for manufacturing sites of common interest.

This collaboration will allow the EMA, EU national authorities (France and the UK), the US Food and Drug Administration (FDA), Australia’s Therapeutic Goods Administration (TGA), Health Canada, the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and the World Health Organization (WHO) to share information on good manufacturing practice (GMP) inspections of manufacturers of sterile medicines that are located outside the participating countries and to organize joint inspections for manufacturing sites of common interest.

The products in scope are sterile medicinal products for human use of chemical origin and certain therapeutic biotechnology-derived products (such as monoclonal antibodies and recombinant proteins). Products currently out of scope of this pilot are vaccines, cell and gene therapies, and plasma-derived pharmaceuticals. 

The pilot will last for a minimum of two years after which the participating authorities will assess the program and determine the next steps in the collaboration.

The EMA says international collaboration in inspections has demonstrated its benefits in improving oversight of manufacturers and making best use of inspection resources worldwide, through reliance between participating regulatory bodies, the reduction of duplication of inspections, and the increase in the coverage of sites inspected worldwide. 

Source: European Medicines Agency