Should TGA publish GMP Certificates?

The Australian TGA is planning to publish GMP Certificates on its website and is looking for feedback on this idea in a Consultation Paper and survey.

Providing information about regulatory activities is an important part of the TGA's commitment to transparency. The TGA currently publishes a list of domestic manufacturers that hold a GMP licence. The list on the TGA website includes the name and address of the manufacturer, and the approved manufacturing steps.

For international manufacturing sites, the TGA issues a GMP Certificate where an inspection confirms compliance with the same GMP requirements applicable to Australian sites. This certificate confirms compliance with GMP principles for a defined scope of manufacturing activities and for a specified period. GMP certificates are distinct from the manufacturing licence issued to manufacturing sites in Australia. TGA has not published lists of international manufacturers that it has inspected. The TGA is now proposing to publish the outcomes of all GMP inspections, as well as the GMP certificates for international manufacturing sites. This recognises increased public interest in transparency and aims to strengthen public confidence in the oversight of domestic and international manufacturing sites.