The TGA made a commitment to support the MHRA‘s new Regulations worldwide recognition framework for pharmaceuticals. Following the UK’s exit from the European Union, a new international recognition framework for medicines has been developed specifically for them. These international recognition routes- external sites made possible by already-established international collaborations like those created through the Access Consortium and Project Orbis, are a part of this framework. By the first quarter of 2024, the new framework will be in place, which will enable MHRA regulations to use the work of regulatory judgments made by the seven designated foreign regulatory equivalents
TGA collaborates closely with other authorities and draws on its international networks to regulate prescription medications, reducing the regulatory burden on sponsors and bringing safe and effective goods to patients as rapidly as feasible. For sponsors to submit applications,
- The TGA currently has numerous application procedures in place, including the Comparable Overseas Regulator (COR) approach.
- The COR routes have been in place in Australia for some years and enable the TGA to rely on evaluations from reputable authorities such as the MHRA and others.
The TGA’s overseas Engagement Strategy 2021-2025 explains how collaborating with our overseas regulatory colleagues would benefit Australians by creating a more internationally harmonized regulatory environment.
Connect with Us
Subscribers to the Morulaa website may get the most recent and pertinent medical news from the FDA, TGA, Australia, MHRA, MDA, and other countries. If you want to help with the registration of a medical device in India or other Southeast Asian countries, get in contact with us.
Source: TGA Support MHRA New System
