Access 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
• 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)

Learn more about the Access Consortium

Access Consortium Strategic Plan 2025-2028

Our 2025-2028 strategic plan aims to solidify our regulatory collaboration in the coming years. Our vision remains focused on enhancing cooperation among member countries to streamline procedures and improve access to safe, effective medicines. We aim to create an environment that benefits patients, industry partners, and regulators. The plan focuses on strengthening our collaboration, aligning expectations with industry, and improving our communication. We're also introducing a cloud-based workspace to allow joint reviews and enhance our efficiency.

Our key objectives are:

• Strengthening work-sharing
• Expanding our lifecycle approach
• Supporting regulatory innovation
• Enhancing stakeholder engagement

We continue to encourage joint applications, especially those involving all member countries, as these bring the most benefits.

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 regulatory information and work sharing initiatives including but not limited to:

• Biosimilars
• 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.

Related resources

• Access Consortium's Advanced Therapy Medicinal Products Working Group
• Access Consortium offers pipeline meetings to pharmaceutical and biotechnology companies
• Access Consortium statement on Good Manufacturing Practice inspections reliance and recognition evidence
• Access Consortium - New Active Substance (NAS) Working Group
  • Operational procedures for New Active Substances Work-Sharing Initiative (NASWSI)
  • 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 collaboration@hc-sc.gc.ca
• Access Consortium statement on COVID-19 medicines
• Access Consortium: Alignment with IMCRA consensus on immunobridging for authorizing new COVID-19 vaccines
• 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
    • Face-to-Face Meeting - May, 2018
  • Generic Medicines Work Sharing Initiative (GMWSI)
    • Notice to Applicants - Request for Expressions of Interest (EoI)
    • Generic Medicines Expression of Interest (EoI) Form (PDF Version)
      Expression of Interest (EoI) Form (DOC Version)
    • Generic Medicines Operational Procedures (OP)
• Access Consortium - Biosimilars Working Group (BSWG)
  • Facilitating Access Consortium Work Sharing for Biosimilars
    • Expression of Interest (EOI) Form available upon request at collaboration@hc-sc.gc.ca