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 Reference119 KB.

Access Strategic Plan 2021-2024

The Consortium has developed the Strategic Plan for 2021-2024. With our combined populations of 150 million, the Consortium aspires to be regulators of choice. This plan will guide Access toward enhanced efficiency of our national regulatory systems, while optimising synergies and alignment between regulatory authorities and reducing duplication for industry.

For more information, please refer to the Access Strategic Plan 2021-2024516 KB.

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 Procedures179 KB for more details.

Applicants who are interested in participating in this initiative can submit the completed Expression of Interest Form181 KB 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 Mandate176 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 form94 KB to HSA_TP_Enquiry@hsa.gov.sg 

Biosimilars Working Group

Biosimilars Working Group (BSWG)

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 Industry179 KB for more details.

Applicants who are interested to participate in this initiative can submit the completed Expression of Interest form125 KB to HSA_TP_Enquiry@hsa.gov.sg.

Clinical Trials Working Group

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

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