The ACSS (Australia-Canada-Singapore-Switzerland) Consortium and the Generic Medicines Work Sharing Trial

Author: Bhavesh Patel, C. Chem.

Last month the ACSS Consortium announced the launch of the Generic Medicines Work Sharing Trial, an innovative work sharing model for the coordinated assessment of applications for generic medicines. The trial will undertake a coordinated assessment of a generic product application to assist the regulatory decision-making within each jurisdiction.

To participate in the Trial, applications should be submitted simultaneously to at least two of the ACSS Consortium members. The lead agency, also known as the Reference Regulatory Agency, will prepare assessment reports following a review of the application. The application will also receive supplementary review by other consortium members.

The ACSS Consortium is a collaborative initiative between Australia’s Therapeutic Goods Administration, Health Canada, Singapore’s Health Sciences Authority, and the Swiss Agency for Therapeutic Products.

The Consortium voluntarily meets on a regular basis to exchange information on issues and challenges. While informal, the collaboration aims to achieve regulatory consistency between the different regimes with the goal of reducing the regulatory burden. The ACSS Consortium has been and continues to serve as a “testing ground” for new and innovative collaborative approaches and can act as a pilot forum for larger international initiatives, for example the International Generic Drugs Regulators Programme.

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