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GMP clearance for overseas manufacturers

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16 May 2011

Appendix B - International agreements

Countries which are recognised participants in an MRA (or equivalent) with Australia

Austria
Belgium
Canada
Cyprus
Czech Republic
Denmark
Finland

France
Germany
Greece
Hungary
Iceland
Ireland
Italy

Liechtenstein
Luxembourg
Malta
Netherlands
Norway
Portugal
Singapore

Spain
Sweden
Switzerland
United Kingdom

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.

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 the Pharmaceutic Inspection Co-operation Scheme website.

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.

Other international agreements entered into by the TGA
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 Department of Health Housing Local Government and Community Services
Memorandum of Understanding Exchange of information in relation to manufacturers for regulatory purposes
Switzerland
Swiss Confederation regarding Therapeutic Products
Memorandum of Understanding (arrangements generally equivalent to an MRA) Exchange of information relating to the regulation of medicines GMP inspections and post market monitoring of therapeutic products.

The TGA also participates in other agreements with agencies with a view to increase international cooperation and capacity building. Generally they do not support the exchange of GMP certifications and inspection reports.

Note: The above information is current as at May 2011.

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