Author: Grant Bamdé, Associate Director, Team Lead, Regulatory Affairs, Australia
The Therapeutic Goods Administration (TGA) has been taking steps to streamline and speed up its assessment of medicines, including biopharmaceutical products, with the goal of enabling earlier access to new prescription medicines in Australia. One important method for improving the registration and assessment process has been better use of assessment reports generated by comparable overseas regulators (CORs) during their own evaluation of a medicine.
The COR report-based process is open to registration applications for prescription medicines, and can be used for new chemical entities, new fixed dose combinations, generic medicines, biological medicines and biosimilars where the application has received full overseas marketing approval following a de novo evaluation. This process is also used for extension applications of medicines already approved by the TGA, including indication extensions or new dosage forms and changes to product information documents that would normally require evaluation of clinical data. To be eligible, the application must not have been delayed, deferred, rejected, refused or withdrawn at any time, in any country. While the COR reports are used to assist in the review of the application, the TGA continues to make the final regulatory decision regarding the application. This ensures the quality and safety of the medicine is consistent with the TGA’s own requirements and that the applicability to the Australian population is taken into consideration.
The TGA has implemented two approaches for using overseas reports known as COR-A or COR-B, which are differentiated based on the extent of additional data that will require evaluation by the TGA as part of the assessment. Currency of the information in the reports obtained from the COR is an important determinant of which pathway is appropriate.
The evaluation and decision timeframe for COR-A applications is 120 working days. To be eligible for evaluation by this pathway the application needs to meet specific requirements. The proposed medicine and manufacturing process must be identical to that approved by the COR and the full overseas marketing approval for the medicine must not be older than one year.
Under COR-A, the TGA regulatory decision will be based on a critical review of the COR assessment reports and an evaluation of the Australian label, Product Information (PI) and, where required, the Risk Management Plan (RMP) with no additional evaluation of Australian-specific data required.
Under the COR-B approach, the TGA regulatory decision will still be mostly based on a critical review of the COR assessment reports, however, due to differences in the data supplied with the reference application, the TGA need to review additional data. The COR-B process has a 175 working day evaluation and decision timeframe, allowing for TGA evaluation of the extra information. Examples of additional data that may be reviewed – beyond the label, PI and RMP — include updated stability data, validation data for an additional manufacturing site and updates to pivotal studies that support the proposed indication.
For COR-B applications, there is no time limit for how long ago the medicine received overseas approval. However, depending on the amount and type of additional data requiring evaluation, the COR-B pathway may be deemed unsuitable, in which case assessment as a standard Category 1 application will be necessary.
Comparable Overseas Regulators
The TGA has identified the health authorities of Canada (Health Canada), Japan (Pharmaceuticals and Medical Devices Agency), Singapore (Health Science Authority Singapore), Switzerland (SwissMedic), the United Kingdom (Medicines and Healthcare products Regulatory Agency) and the United States (Food and Drug Administration) as well as the centralised and decentralised processes of the European Union (European Medicines Agency) as CORs whose reports are acceptable for the COR report-based evaluation process. These authorities have been recognised as having a similar regulatory framework to the TGA in terms of pre- and post-market activities, with transparent assessment processes and use of international guidelines and standards consistent with those adopted by the TGA. These regulators also have established a formal and robust framework for cooperation with the TGA and are able to conduct their business in English.
The TGA recognises that there can be some variability in the expression of indications, based on local influences such as clinical practice or clinical needs or, in the case of generic medicines, the indication of the overseas reference product. For this reason, the proposed indication for Australia is not required to be identical but must be equivalent in terms of same dosing range, patient population and outcome. For generics and biosimilars, the proposed indication must be identical to the indication approved for the originator within Australia.
General application requirements
All applications must meet existing Australian requirements, including GMP. The application must be in electronic Common Technical Document (eCTD) format, applicants must submit the complete dossier that was submitted to the COR with an Australian-specific Module 1. This must include a defined set of the final COR assessment documents specific to each of the recognised agencies, complete and unredacted, in English.
Due to differences in regulatory frameworks and process requirements, there may be certain applications that are not suited for the COR report-based processes (for example, medicines that include a medical device component). For this reason, pre-submission engagement with the TGA to discuss the suitability of an application for assessment via the COR pathways is encouraged.
If you would like advice on registration or approval using an evaluation undertaken by a comparable overseas regulator, please contact our team who have significant experience in this area.
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