Health Canada is collaborating with our international partners on issues related to drug and medical device clinical trials, authorizations, risk assessments, and potential shortages. Learn about how we are engaging our international partners on COVID-19 health products issues.
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
- Swissmedic, Swiss Agency for Therapeutic Products, of Switzerland
- the Medicines and Healthcare products Regulatory Agency (MHRA), of the United Kingdom (joined on October 14, 2020)
To learn more about the future envisioned for Access, consult the Access Consortium Strategic Plan for 2021-2024.
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 regulatory information and work sharing initiatives including but not limited to:
- Complementary Medicines
- Generic Medicines
- Information Technology
- New Active Substances
The Consortium also coordinates the involvement of technical experts in the International Conference on Harmonisation (ICH) working groups.
- Access Consortium - Regulators pledge support to tackle COVID-19
- Access Consortium statement on COVID-19 vaccines evidence
- Access Consortium guidance on modifications to COVID-19 vaccines to address new variants of coronavirus
- Access Consortium - Generic Medicines Working Group (GMWG)
- GMWG - Mandate
- GMWG - Meetings
- Generic Medicines Work Sharing Trial (GMWST)
- Notice to Applicants - Request for Expressions of Interest (EOI)
- Expression of Interest (EOI) Form available upon request at email@example.com
- Operational Procedures (OP)
- Questions and Answers (Q&A)
- Access Consortium - New Active Substance (NAS) Working Group
- Notice to Industry: New Chemical Entities Work Sharing Trial Phase I
- Access Consortium: New Active Substance Work Sharing Initiative (NASWSI) Overview
- Expression of Interest (EOI) Form available upon request at firstname.lastname@example.org
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