Description of the Head of Australia, Canada, Singapore, Switzerland Agencies Consortium

 

Globalisation of health products including rapid emergence of new technologies, increased international flow of health products and limited resources affects the capacity of a single regulatory agency to address health risks and promote timely access to safe therapeutic products. Recognising these challenges and the importance of international collaboration among like-minded health regulatory agencies, the Head of Agencies Consortium was established in 2007 as a means to promote regulatory convergence and foster synergy to address scientific and regulatory issues (Terms of Reference).

The Consortium consists of health regulatory agencies from:

• the Therapeutic Goods Administration (TGA) of Australia,
• the Health Products and Food Branch (HPFB) of Health Canada, Canada
• the Health Sciences Authority (HSA) of Singapore, and
• Swissmedic, Swiss Agency for Therapeutic Products, of Switzerland

Meetings

The Consortium voluntarily meets on a regular basis to exchange information on issues and challenges. While informal, its collaboration aims to better align the regulatory systems and reduce unnecessary duplication and differences.

Focus of work

The Consortium's work focuses on concrete regulatory work sharing initiatives including but not limited to:

• Good Manufacturing Practices (GMPs),
• Good Review Practices (GRPs),
• Post-market medicines safety and surveillance,
• Assessment reports for pharmaceuticals including generic drugs and new chemical entities, and
• Coordination of involvement of technical experts in the International Conference on Harmonisation (ICH) working groups, and the collaboration on the Information Technology (IT)-architecture.