As a trusted regulatory partner, TGA is committed to support the new international recognition framework that MHRA is introducing for medicines. These international recognition routes, which have been facilitated by existing international partnerships such as those developed through the Access Consortium and Project Orbis, are part of a new international recognition framework for medicines that is specific to the UK following their exit from the European Union. The new framework will allow MHRA to utilise the work of, and regulatory decisions made by the seven nominated international regulatory counterparts, to assist in their sovereign decision-making and will be in place by the first quarter of 2024.
TGA works closely with other regulators and relies upon its international networks in the regulation of prescription medicines, where possible to reduce the regulatory burden on sponsors and bring safe and effective products to patients as quickly as possible. TGA currently has several application pathways in place for sponsors to submit applications, including the Comparable Overseas Regulator (COR) pathway. The COR pathways have been in-place in Australia for several years and allow TGA to makes use of assessments from trusted regulators, such as the MHRA and others.
The TGA’s International Engagement Strategy 2021-2025 further describes how working with our international regulatory counterparts will benefit Australians through a more globally aligned regulatory framework.
