Author: Pinky Mazumder
With the evolving nature of medicines and treatments, regulatory agencies across the world are encountering similar challenges during the review and evaluation of marketing applications and drug submissions. As a result, the Therapeutic Goods Administration (Australia), Health Canada, Health Sciences Authority (Singapore), and the Swiss Agency for Therapeutic Products (Switzerland) collaborated to form the Australia Canada Singapore Switzerland (ACSS) Consortium (the “Consortium”). The creation of the Consortium allows these regulatory agencies to discuss ways to enhance and even align the regulatory reviews of certain drug products.
The ACSS consists of multiple working groups, including the New Chemical Entities (NCE) Working Group, which recently launched a pilot work-sharing project. The NCE work sharing pilot aims to allow for a shared assessment and evaluation of a NCE drug application that has been submitted to two of the regulatory agencies. This would help alleviate challenges for the regulators when encountering difficult decision making during drug reviews. In addition, this pilot project could also benefit the pharmaceutical industry by helping to reduce regulatory burden and supporting concurrent drug submissions.
The ACSS NCE working group is currently seeking applications from the industry to explore the opportunities with this pilot project. Interested parties should submit the “Expression of Interest” form to at least two of the Consortium regulatory agencies. Due to regional differences in contents of the eCTD Module 1 of the submission, each regulatory agency will review its respective Module 1. However, Module 3 Quality will be reviewed by Health Canada while the TGA reviews Module 4, but both regulators will evaluate Module 5 Clinical. For the pilot process, it will be preferred if Module 2-5 of the submission contains common information to allow for the aforementioned division of review responsibilities for the regulators. In case of differences in Module 2-5, the stakeholder should clearly highlight the differences in the Expression of Interest application form. If you are a part of the industry and are interested in participating in the ACSS NCE work sharing pilot, please contact the regional contact for Canada via email at HC.tpd.international-dpt.SC@canada.ca.
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