Action of proving, in accordance with the principles of GMP, that any procedure, Validation process, equipment, material, activity or system actually leads to the expected results. Appendix B International agreements – Countries which are recognised participants in an MRA (or equivalent) with Australia Austria France Liechtenstein Spain Belgium Germany Luxembourg Sweden Canada Greece Malta Switzerland Cyprus Hungary Netherlands United Kingdom Czech Republic Iceland Norway Denmark Ireland Portugal Finland Italy Singapore Notes: A TGA on-site audit will always be required where the listed or registered medicines are not regulated by the regulatory agency in their own country. are commonly Complementary Medicines and Traditional Chinese Medicines not regulated as medicines in other countries. This list is subject to revision as new EU-member countries acquire MRA status GMP agreements and arrangements with Competent Regulatory Authorities The TGA is a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The PIC/S aims to develop harmonised regulatory guidelines and facilitate the training and development of inspectors. PIC/S membership is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity. PIC/S membership also provides for the confidential exchange of regulatory information including the planning of inspections, compliance status of a manufacturer and the results of inspections. The TGA does not automatically accept GMP Certification from PIC/S member countries unless also covered by an MRA with Australia. Certificates and inspection reports from an overseas regulator for inspections that predate its official membership to PIC/S will not be accepted. A list of PIC/S member countries is available at www.picscheme.org/members.php. The TGA has entered into various other international agreements to support information sharing and other desirable objectives for international regulatory collaboration. These agreements do not permit legally enforceable acceptance of the decisions of the other party, but may be used to enhance regulatory oversight and significantly reduce regulatory burden without diminution of compliance. Organisation Agreement Scope Cooperation agreement/ confidentiality Exchange of information in USA undertakings relation to manufacturers for Food and Drug regulatory purposes. Administration Exchange of information in European Directorate for the Co-operative arrangement between relation to the manufacture of Quality of Medicines the TGA and the European APIs and excipients used in the (EDQM) Directorate for the Quality of manufacture of therapeutic Medicines and Healthcare Council of goods. Europe Memorandum of Understanding Exchange of information in New Zealand: relation to manufacturers for Medsafe
Validation Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results. Appendix B – International agreements Countries which are recognised participants in an MRA (or equivalent) with Australia Austria France Liechtenstein Spain Belgium Germany Luxembourg Sweden Canada Greece Malta Switzerland Cyprus Hungary Netherlands United Kingdom Czech Republic Iceland Norway Denmark Ireland Portugal Finland Italy Singapore Notes: A TGA on-site audit will always be required where the listed or registered medicines are not regulated by the regulatory agency in their own country. Complementary Medicines and Traditional Chinese Medicines are commonly not regulated as medicines in other countries. This list is subject to revision as new EU-member countries acquire MRA status GMP agreements and arrangements with Competent Regulatory Authorities The TGA is a member of the Pharmaceutical Inspection Cooperation Scheme (PIC/S). The PIC/S aims to develop harmonised regulatory guidelines and facilitate the training and development of inspectors. PIC/S membership is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity. PIC/S membership also provides for the confidential exchange of regulatory information including the planning of inspections, compliance status of a manufacturer and the results of inspections. The TGA does not automatically accept GMP Certification from PIC/S member countries unless also covered by an MRA with Australia. Certificates and inspection reports from an overseas regulator for inspections that predate its official membership to PIC/S will not be accepted. A list of PIC/S member countries is available at www.picscheme.org/members.php. The TGA has entered into various other international agreements to support information sharing and other desirable objectives for international regulatory collaboration. These agreements do not permit legally enforceable acceptance of the decisions of the other party, but may be used to enhance regulatory oversight and significantly reduce regulatory burden without diminution of compliance. Organisation Agreement Scope USA Food and Drug Administration Cooperation agreement/ confidentiality undertakings Exchange of information in relation to manufacturers for regulatory purposes. European Directorate for the Quality of Medicines (EDQM) Co-operative arrangement between the TGA and the European Directorate for the Quality of Medicines and Healthcare Council of Europe Exchange of information in relation to the manufacture of APIs and excipients used in the manufacture of therapeutic goods. New Zealand: Medsafe Memorandum of Understanding Exchange of information in relation to manufacturers for