The European Medicines Agency and the European Commission have had confidentiality arrangements with the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health and Ageing since 2012, to allow the exchange of information between the parties as part of their regulatory and scientific processes. The European Union (EU) and Australia also have a mutual recognition agreement (MRA) in place on good manufacturing practice (GMP) compliance.
EMA, the European Commission and TGA signed a confidentiality arrangement in 2012.
The confidential information that EMA and TGA can share includes:
- guidance documents, policies, procedure and other technical documents;
- post-authorisation pharmacovigilance data, particularly in relation to adverse drug reactions, as well as safety concerns arising from periodic safety update reports and post-authorisation obligations and commitments;
- applications for scientific advice, orphan designation, marketing authorisation or post-authorisation activities of significant public health interest and complementary medicine listings;
- cases, or possible cases, of counterfeit therapeutic goods and medicines;
- risk management plans;
- administrative arrangements including fees and charges;
- information technology systems supporting regulatory processes.
Exchange of letters
- Confidentiality arrangement: Letter from EMA to TGA of the Australian Government Department of Health and Ageing (1/10/2012)
- Confidentiality arrangement: Letter from TGA of the Australian Government Department of Health and Ageing to EMA (1/10/2012)
MRA and collaboration on GMP compliance
- rely on each other's GMP inspections of manufacturers in their respective territories;
- waive batch testing of products on entry into their territories;
- share information on inspections and quality defects.
For more information on MRAs and the scope of the EU-Australia MRA, see Mutual recognition agreements.
EMA also participates in initiatives with partner authorities, including the TGA, on GMP inspections which aim to better distribute inspections capacity, allowing more sites to be monitored and reducing unnecessary duplication. For more information, see International collaboration on GMP inspections.
The agencies, together with other non-EU regulators, hold regular meetings by phone or videoconference in so-called 'clusters'.
The clusters are areas of cooperation focusing on special topics and therapeutic areas identified as requiring an intensified exchange of information and collaboration.
For more information, see Cluster activities with regulatory partners.