Following a 2016 regulation that aimed to improve access to medical products in Australia, the Therapeutic Goods Administration (TGA) has implemented criteria to aid pharmaceutical companies in identifying comparable overseas regulators (COR), including a formal process for work-sharing on drug applications using foreign reports. This comes at a time when regulators around the world are looking to harmonise regulatory requirements and reduce duplicative work through mutual recognition agreements.
TGA has separated 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 is in place to help ensure that a foreign regulatory agency is similar enough to TGA in order to collaborate on drug applications. The second stage focuses on the specific characteristics of a given application. The TGA has stated that the criteria will “help identify opportunities for enhanced international collaboration in the regulation of prescription medicines”.
The TGA aims to use the parameters that are set through the second stage to determine whether a COR work-sharing agreement can be established or if a COR assessment report can be used for regulatory purposes, instead of undertaking a de novo evaluation of the submission.
Furthermore, the work-sharing process for drug applications will allow 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 will result in a joint evaluation report for the regulators to each reach their own decisions on an application.
The CORs that can currently 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 and Switzerland Consortium. However, TGA stated that the work-sharing approach is “still in the early stages of development and requires the cooperation of multiple regulators”.
To read more about CORs for prescription medicines, please click here.