Australia Proposes Ongoing API Inspection Cooperation
Posted 05 March 2012 | By
Australia's Therapeutic Goods Administration (TGA) said 2 March that it is working to establish "an ongoing collaboration in international inspection of [Active Pharmaceutical Ingredient (API)] manufacturers and [an] increase in the number of regulators participating" in their good manufacturing practice (GMP) pilot program.
TGA noted that this collaboration has resulted in a governing document for the program, which will allow the World Health Organization to become a new partner.
The document is "the first step the expansion of the international program which fosters cooperation and sharing of resources between regulators for a better inspectional coverage of API manufacturers worldwide and contributes to the realization of the WHO objective of safe and effective medicines for all," said TGA.
TGA - Update: Improving international cooperation between regulators