Regulatory Focus™ > News Articles > Australia Proposes Ongoing API Inspection Cooperation

Australia Proposes Ongoing API Inspection Cooperation

Posted 05 March 2012 | By Alexander Gaffney, RAC 

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.

Read more:

TGA - Update: Improving international cooperation between regulators


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