If you have suitable evidence available, you may be able to apply for GMP clearance through the Mutual Recognition Agreement (MRA) and Compliance Verification (CV) pathways rather than obtaining TGA GMP Certification.
Specific information on the MRA and CV pathways can be found on the GMP approach to overseas manufacturers page of the TGA website.
MRA and CV evidence requirements
The TGA has entered into various international agreements and arrangements with other regulators to support international regulatory collaboration. Some of these allow us to use inspections conducted by these regulators for GMP clearance purposes, in lieu of conducting our own on-site inspections.
The MRA and CV pathways to GMP clearance are only available if the relevant overseas regulator has recently inspected the manufacturing site to a GMP standard equivalent to the TGA's for the type of therapeutic good produced there.
It is often not possible to obtain GMP clearance using evidence from another regulator because of differences in the regulatory frameworks and GMP standards for:
- listed medicines including sunscreens
- biologicals, blood and blood components and haematopoietic progenitor cells
If you are unsure whether you have suitable evidence to apply for a GMP clearance through the MRA or CV pathways, please contact the Manufacturing Quality Branch.