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About the Access

The 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 Access 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 MHRA will officially commence working with consortium partners as a full member on 1 January 2021. 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 Access 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 Access explores opportunities for information and work-sharing initiatives.

For more information, please refer to the Terms of Reference143 KB.

 

Access working groups for therapeutic products

New Active Substance Working Group

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 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

Approvals by HSA under the NASWI

Tafamidis

The Health Sciences Authority (HSA) has approved the new drug applications (NDA) for Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) on 27 February 2020, evaluated under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium New Active Substance Work Sharing Initiative. These are the first NDA that HSA approved through collaborative review with an ACSS partner regulatory agency.

The applications were simultaneously submitted to HSA and the Australian Therapeutic Goods Administration (TGA). Technical reviews were divided between the two authorities and subsequently shared. Upon completion of the review, each agency made independent decisions regarding the approval of the medicines.

Vyndaqel and Vyndamax are now registered in both Singapore and Australia for transthyretin amyloid cardiomyopathy (ATTR-CM), a cardiac muscle dysfunction caused by the accumulation of abnormal protein strands (transthyretin amyloids fibrils) on the cardiac walls.

Generic Medicines Working Group

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 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 

Approvals by HSA under the GMWSI

Posaconazole

The Health Sciences Authority (HSA) has approved the generic drug application for Posaconazole Sandoz Gastro-Resistant Tablets on 9 March 2020, evaluated under the Australia-Canada-Singapore-Switzerland (ACSS) Consortium Generic Medicines Work Sharing Initiative. This is the first generic medicine that HSA approved through collaborative review with ACSS partner regulatory agencies.

The applications were submitted to HSA, Health Canada and the Australian Therapeutic Goods Administration (TGA), with Health Canada acting as the Reference Regulatory Agency (RRA), while HSA and TGA were the Concerned Regulatory Agencies (CRAs). The technical review was performed by the RRA with supplementary input from the CRAs. Upon completion of the review, each agency made independent decisions regarding the approval of the medicine. Posaconazole Sandoz Gastro-Resistant Tablet is now registered in all three countries for the prophylaxis and treatment of fungal infections. 

Meetings and Communications

The GMWG meets bi-annually and also holds regular teleconferences to advance the work. For more information about the proceedings and notable outcomes from the face-to-face meetings, please refer to the Public Statements:

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Applicants who are interested in participating in this initiative can submit the completed Expression of Interest form (Word version) to HSA_TP_Enquiry@hsa.gov.sg