Access Consortium
Find out about the collaborations under the Access Consortium for therapeutic products
Last updated 7 April 2026
News
13 Dec 2023: New Access Work-sharing Pathway for Priority Procedures
24 April 2023: Access Consortium offers pipeline meetings to pharmaceutical and biotechnology companies
15 Nov 2022: Access Consortium Statement on Good Manufacturing Practice (GMP) Inspections Reliance and Recognition
14 Dec 2021: Access Consortium statement on COVID-19 medicines
16 Sep 2021: Access Consortium statement on alignment with ICMRA consensus on immunobridging for authorizing new COVID-19 vaccines
22 Jun 2021: Access Strategic Plan 2021-2024
4 Mar 2021: Access Consortium's guidance on strain changes in authorised COVID-19 vaccines
4 Dec 2020: Access Consortium statement on COVID-19 vaccines evidence
4 Dec 2020: Access Consortium regulators pledge support to tackle COVID-19
14 Oct 2020: ACSS Consortium welcomes U.K. as its newest member and changes its name to Access Consortium [PDF, 91 KB]
About Access
Access is a coalition of like-minded medium-sized regulatory authorities. The participating authorities face very similar challenges, such as increasing workload, increasing complexity and at the same time increasing pressure on the available resources.
The Consortium was renamed from the previous Australia-Canada-Singapore-Switzerland Consortium (ACSS) in October 2020, with the introduction of its newest consortium member, the U.K. Medicines and Healthcare products Regulatory Authority (MHRA). The new name reflects the group’s key aim of providing patients with timely access to high-quality, safe and effective therapeutic products in the member countries.
The members of the Access consists of health regulatory agencies from:
Therapeutic Goods Administration (TGA) of Australia;
Health Canada of Canada;
Health Sciences Authority (HSA) of Singapore
Swissmedic of Switzerland; and
Medicines and Healthcare products Regulatory Authority (MHRA) of the United Kingdom (effective 1 Jan 2021)
The Consortium meets on a regular basis to exchange information on issues and challenges. The collaboration aims to better align the regulatory systems and reduce unnecessary duplication and differences.
The Consortium also explores opportunities for information and work-sharing initiatives.
For more information, please refer to the Terms of Reference [PDF, 123 KB].
Access Strategic Plan 2025-2028
Access Consortium is pleased to present our updated strategic plan, which outlines our approach to regulatory collaboration for the coming years.
Our vision remains focused on enhancing cooperation amongst member countries to streamline procedures and improve access to safe, effective medicines. We aim to create an environment that benefits patients, industry partners, and regulatory bodies alike.
The renewed plan emphasises solidifying our collaborative processes, aligning expectations with industry, and improving our communication strategies. We're introducing a new cloud-based workspace to facilitate joint reviews, which we believe will enhance our efficiency.
Our key strategic objectives are:
Strengthening work-sharing initiatives
Expanding our lifecycle approach
Supporting regulatory innovation
Enhancing stakeholder engagement
We continue to encourage joint applications, particularly those involving all member countries, as these offer the greatest collaborative benefits.
For more information, please visit our newly launched Access webpage: https://accessconsortium.info/
Access working groups for therapeutic products
New Active Substance Working Group
New Active Substance Working Group (NASWG)
The New Active Substance Working Group (NASWG) was established with the objective of creating opportunities and regulatory programmes for workshare through the greater alignment of regulatory approaches and technical requirements for medicines. This is in view of the challenges faced by regulatory agencies, in particular the pressure on available resources to ensure timely access to effective new therapies with increasing workload and complexities of applications.
New Active Substance Work Sharing Initiative (NASWSI)
The New Active Substance Work Sharing Initiative (NASWSI) is an innovative work sharing model for the coordinated assessment of an application that has been filed with multiple consortium agencies.
The NASWG is currently actively seeking applications for this initiative, which covers new chemical or biological entity applications that are submitted to at least two consortium agencies.
Please refer to the Operational Procedures [PDF, 186 KB] for more details.
Applicants who are interested in participating in this initiative can submit the completed Expression of Interest form to HSA_TP_Enquiry@hsa.gov.sg
Generic Medicines Working Group
Generic Medicines Working Group (GMWG)
The Generic Medicines Working Group (GMWG) was established with a specific focus on issues relating to generic medicines. The GMWG aims to:
Create 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
Establishment of an effective network among trusted, like-minded regulatory authorities
Produce immediate and ongoing results in priority work areas; and
Serve as a “proof of concept” for other international regulatory cooperation initiatives.
Please refer to the GMWG Mandate [PDF, 180 KB] for more details on the GMWG and its scope of activities.
Generic Medicines Work Sharing Initiative (GMWSI)
The Generic Medicines Work Sharing Initiative (GMWSI) is an innovative work sharing model for the coordinated assessment of a generic application that has been filed with multiple consortium agencies.
The GMWG is currently actively seeking applications for this initiative, which covers applications submitted to at least two consortium agencies.
Please refer to the following documents for more details:
Applicants who are interested in participating in this initiative can submit the completed Expression of Interest form to HSA_TP_Enquiry@hsa.gov.sg
Biosimilars Working Group
The Biosimilars Working Group (BSWG) was established with the objective of creating opportunities and regulatory programmes for workshare through the greater alignment of regulatory approaches and technical requirements for biosimilar medicines.
This is in view of the challenges faced by regulatory agencies, particularly the pressures on available resources to ensure timely access to effective alternatives to biologic medicines with increasing workload and complexities of applications.
Biosimilars Work Sharing Initiative (BSWSI)
The BSWG is currently seeking biosimilar applications for work sharing between at least two consortium agencies.
Please refer to the Guidance for Industry [PDF, 184 KB] for more details.
Applicants who are interested to participate in this initiative can submit the completed Expression of Interest form to HSA_TP_Enquiry@hsa.gov.sg.
Clinical Trials Working Group (CTWG)
A new Clinical Trials Working Group is now established under the framework of the Access Consortium.
The main goal of this group is to increase the collaboration in the area of clinical trials with the objective of harmonizing technical and regulatory requirements, exchange information on new developments and explore possibilities of work-sharing among our Agencies.
Advanced Therapy Medicinal Products Working Group (ATMG WG)
In 2023, the Access Consortium established a working group for advanced therapy medicinal products (ATMPs). ATMP is a term used in the legislative framework implemented by the European Union to regulate cell therapies, gene therapies and tissue engineering products.
The main goals of this group are to:
foster interdisciplinary (quality, non-clinical, clinical) scientific discussions on emerging innovative therapeutic concepts and technologies
establish an interdisciplinary forum for Access members to discuss ATMP-specific topics with a focus on assessing benefits and risks and on regulatory decision-making
encourage mutual exchange and harmonization on the regulatory assessment of ATMPs
explore potential synergies and opportunities for work-sharing, reliance and providing joint scientific advice
publish guidance and recommendations on common areas where the group has established a harmonized approach, where appropriate