API GMP inspections collaboration to include Japan

Japan has joined the existing international collaboration on good manufacturing practice (GMP) inspections for active pharmaceutical ingredients (APIs). The Japanese Pharmaceutical and Medical Devices Agency (PMDA) will collaborate with EMA, EU Member State authorities, the European Directorate of the Quality of Medicines and Healthcare (EDQM), the United States Food and Drug Administration (FDA), the Therapeutic Goods Administration (TGA) in Australia, Health Canada and the World Health Organization.

This international collaboration will see the sharing of information on inspections of API manufacturers that are located outside the participating countries. The overall aim is increased collaboration and dependence between the participating regulatory agencies. The initiative also has the benefit of ensuring efficient use of inspection resources worldwide.

It is good to see a further regulatory agency information sharing which should reduce the burden of work associated with API GMP inspections for pharmaceutical companies and manufacturers.

To read the full announcement on the EMA website, please click here.