Australia Implements Process for Comparable Overseas Regulators
Posted 15 June 2018 | By
Following a 2016 regulation aimed at improving access to medical products in Australia, the Therapeutic Goods Administration (TGA) has implemented criteria to aid pharmaceutical companies in identifying comparable overseas regulators (COR), as well as a formal process for work-sharing on drug applications using foreign reports.
The clarifications come at a time when regulators around the world are looking to harmonize regulatory requirements and reduce duplicative work through mutual recognition agreements
TGA separates the application of the described COR criteria into two stages, with four criteria for the first stage and nine for the second. The first stage helps to ensure that a foreign regulatory agency is similar enough to TGA for collaboration on drug applications, while the second is centered on the specific characteristics of a given application.
The Australian agency intends to use the parameters set through the second stage to determine whether a COR work-sharing agreement can be established or a COR assessment report can be used for regulatory purposes, rather than conducting a de novo
evaluation of the submission.
“These criteria help identify opportunities for enhanced international collaboration in the regulation of prescription medicines,” TGA said.
Further, the work-sharing process for drug applications allows for various regulators to simultaneously review different components of a submission in the context of the regulatory requirements in each of the participating regulators’ jurisdictions. This results in a joint evaluation report for the regulators to each reach their own decisions on an application.
The CORs that can take part in the work-sharing process include Health Canada, the Health Sciences Authority of Singapore and Swissmedic--all of which are members of the Australia, Canada, Singapore Switzerland Consortium.
Yet the work-sharing approach is “still in the early stages of development and requires the cooperation of multiple regulators,” TGA said. "The TGA will continue its efforts to further develop work-sharing arrangements over the next few years.”
Comparable overseas regulators (CORs) for prescription medicines