New guidelines for collaboration with overseas regulators were issued on June 15th 2018 by the TGA.
Australia’s Therapeutic Good Administration (TGA) has issued a guidance for a framework to enable regulatory review work-sharing with countries that are part of the Australian, Canada, Singapore Switzerland Consortium which is heavily harmonized. Under the new guidance, prescription medicines (pharmaceutical products) applicants will be able to leverage their applications in these countries for work-sharing reviews and Comparable Overseas Regulators (COR) report-based processes.
The COR process has 2 phases:
Stage 1: Sets out the criteria to evaluate COR eligibility and establishment of substantial similarity between the TGA and the overseas agency to support collaborative work.
Stage 2: Establishes the parameters that will be used to evaluate the COR assessments and reports instead of undergoing a De Novo Application reviews.
The framework can be studied by clicking here.
The establishment of collaboration pathways with harmonized countries is a good step in the direction of leveraging international approvals in a global regulatory approval context and can help reduce duplicative work. These pathways are set to help medical product manufacturers streamline their approval processes in terms of resources required and timelines. Although the COR based collaboration for work-sharing is with a limited number of countries and is in initial stages requiring cooperation between multiple countries, it is indicative of TGA’s efforts to make the Australian approval process efficient.
We predict similar changes for the TGA for Medical Devices and Diagnostics. This could mean that more novel medical devices could be streamlined through to approval in TGA without necessary requiring CE Mark as the main pathway for approval in TGA. The change would be most welcome in the coming months given the current challenges medical device manufacturers are facing due to the change from MDD to MDR and the new IVDR issued almost simultaneously. This coupled with the revision of ISO 13485 from 2013 to 2016, and the challenges notified bodies will have to maintain their status with the MDR, more and more companies are looking for alternative ways to commercialize their technologies in alternative markets. If executed correctly, a comparable overseas regulators framework with the between Australia’s TGA with the likes of Canada could be an enabling avenue for better healthcare and an overall reduction of costs.
Looking to fly south for warmer weather? We are skilled in all aspects of Australian regulatory and reimbursement requirements and can assist you to prepare and file regulatory submissions to TGA. We can also hold Australian licenses on behalf of international manufacturers. Talk to us today about how to leverage international reviews to achieve TGA registration. Contact us to discuss your needs and how we can help. You can drop us an Email firstname.lastname@example.org or call 1 888-271-5063 (US toll free) ♦ 400-842 7017 (Beijing – toll free) ♦ +61 2 9906 2984 (Sydney)