Australia-Canada-Singapore-Switzerland (ACSS) Consortium

6 December 2017

The TGA is part of the ACSS Consortium along with:

The ACSS Consortium is a medium sized coalition, which was formed in 2007 by 'like-minded' regulatory authorities to promote greater regulatory collaboration and alignment of regulatory requirements.

Its goal is to maximise international cooperation, reduce duplication, and increase each agency's capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products.

The ACSS Consortium explores opportunities for information and work-sharing initiatives in areas including:

  • generic medicines registration
  • assessment reports for new prescription medicines
  • post-market medicine safety monitoring
  • alignment of IT systems for information sharing
  • development of technical guidelines.

The trend towards globalisation of therapeutic products industries and the rapid emergence of new technologies have created an increased need for regulatory bodies to communicate with each other routinely. This maximises the use of up-to-date technical expertise, and ensures a consistent, contemporary approach to assessing the benefits and risks associated with the use of therapeutic products.

The Terms of Reference for the ACSS Consortium were endorsed in June 2017 and will be reviewed and approved annually by the Heads of Agenices or when necessary.

ACSS heads of agencies

The heads of the four agencies meet twice annually in the margins of international meetings or conferences to review progress of the ACSS working groups and approve the work program for the upcoming year.

ACSS working groups

Currently, the ACSS Consortium has a number of active working groups in place, such as the ACSS Generic Medicines Working Group, the ACSS New Chemical Entities/Benefit-Risk Working Group, the ACSS Complementary Health Products Working Group, the ACSS IT Architecture Working Group, and the ACSS Pharmacovigilance Working Group.

ACSS Consortium working group members have teleconferences and meetings on a regular basis to exchange information on regulatory issues and challenges faced by participating regulatory agencies.

ACSS Generic Medicines Working Group

  • The Generic Medicines Working Group has been active since 2012, and is one of the more established and advanced initiatives under the ACSS Consortium umbrella.
  • It is creating opportunities and benefits for regulatory programmes through:
    • greater alignment of regulatory approaches and technical requirements;
    • more efficient use of resources through information and work sharing;
    • the establishment of an effective network among trusted, like-minded regulatory authorities; and
    • the establishment of the Generic Medicines Work Sharing Trial

This working group operates under a rotating chair arrangement. Swissmedic chaired the most recent face-to-face meeting on 6-7 May 2015 in Strasbourg, France. The Public Statement for the Strasbourg face to face meeting is now available.

Previous ACSS public statement: