The table below contains the countries and regulatory authorities with which we currently have a Mutual Recognition Agreement (MRA) or an equivalent agreement/arrangement. The GMP terminal route for manufacturers, which are verified by these supervisory authorities, depends on whether the inspection was carried out within or outside their borders: we have a cooperation agreement with the U.S. FDA. We accept U.S. FDA evidence regarding GMP marketing authorization applications using the CV pathway, regardless of inspection procedure, as long as the inspection has been conducted with a comparable GMP standard. The TGA has concluded several international agreements and agreements with other countries and regulatory authorities to support international regulatory cooperation. Some of these agreements and agreements allow us to use the inspections carried out by these regulators as part of the GMP release procedure instead of our own on-site inspection. The EDQM inspects manufacturers of pharmaceutical active substances (APIs) and adjuvants outside the European Union (EU) on the basis of a separate programme. In most cases, this is the participation of an EU regulator.
After a successful on-site inspection, the EU regulator issues a GMP certificate and uploads it to the EudraGMDP database. Manufacturers and sponsors need to be aware of their responsibilities. For more information, please see: Only Australian production sites can obtain a manufacturing license. We treat information about applications and manufacturers as official information. Learn more about the confidentiality of TGA`s disclosure of confidential information. . We do not accept any evidence from a PIC/S participating authority if: Step 1 will help you determine if this process is appropriate for you. You must also decide whether your products are subject to regulatory and GMP standards that vary in Australia. This is particularly likely for: many regulatory authorities, including the TGA, are members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), which is a non-binding cooperation agreement between the authorities that regulate the GMP for medicines. This joint membership in PIC/S allows us, in certain circumstances, to provide evidence to these regulators through the release route of the GMP CV. National Institute of Pharmacy and Nutrition (OGYEI) Do not start manufacturing for delivery to Australia until a manufacturing license or certification is granted, unless pre-approved.
Federal Agency for Medicines and Health Products (FAMHP) National Agency for Medicines and Health Products (Infarmed) If your data is in one of these categories, you do not receive GMP and you expire all fees you have paid.