TGA updates licencing & certification guidance

4 August 2017

A package of new and updated guidance on licencing and certification processes for manufacturers of medicines and biologicals, has been developed in consultation with the TGA Industry Working Group on GMP (TIWGG), to better support manufacturers and sponsors and provide additional clarity for applicants. The new guidance does not introduce changes to the current process or requirements, existing processes have merely been documented with additional clarity.

The updated package of guidance was published in August 2017 and is now available on the TGA website, on the Manufacturing Therapeutic Goods pages.

The existing process guidelines have been archived and will no longer be accessible.

We strongly encourage you to familiarise yourselves with, and start using, the new guidance as soon as possible.

Enquiries and feedback

The TGA welcomes feedback that helps processes be improved. We would welcome any feedback you have on the updated guidance. You can find our contact details at: Contact details for enquiries about manufacturing therapeutic goods.