Australia, through the TGA, is one of only five non-European Union regulators formally invited to participate by the European Medicines Agency (EMA) on the evaluation of vaccines and therapeutics to combat COVID-19. Other participants in the 'OPEN' initiative are Canada, Japan, Switzerland and the World Health Organisation.
Senior medical officers at the TGA contribute to meetings of the EMA pandemic task force, as well as its human medicines committee, as active participants in the consideration of applications for vaccines and medicines for the treatment of COVID-19 infection. This will greatly assist TGA in understanding the medical and scientific considerations made in the review of these products by the EMA and other major global regulators. While the sharing of commercially confidential information between the regulators is underpinned by comprehensive confidentiality agreements, the OPEN initiative will enhance the transparency of regulatory decision making because the regulatory opinions are open to close peer review from a wider range of medical and scientific experts.
However, participating regulators, including the EMA and the TGA will continue to make fully independent 'sovereign' decisions on whether or not particular products should be approved in Australia, the appropriate patient group for treatment with the product and any conditions to be applied to product registration.
