Why Access Consortium makes sense for industry and regulators
Initially, the members of Access (previously known as ACSS) comprised Australia’s Therapeutic Goods Administration (TGA), Health Canada (HC), Singapore’s Health Sciences Authority (HSA) and Swissmedic.2 In 2020, following its exit from the European Union, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) joined the group.
The members of Access are committed to a goal of making it an efficient pathway of choice and increasing the number of applications assessed through work-sharing initiatives.1 As of October 2026, the Access Consortium Strategic Plan 2025-2028 keeps the goal of making Access "a competitive and efficient submission pathway of choice for industry" and aims to increase the number of products and risk management plans assessed through Access collaboration.13
Over the years, Access has expanded the ways in which it engages with industry. For example, in 2023, the consortium began offering joint pipeline meetings to companies, enabling an exchange of information on new developments and an opportunity to collaborate on potential candidates, such as advanced therapy medicine products.5
It is highly recommended that companies take advantage of these pipeline meetings to clarify any issues and avoid any country-specific differences between the health authorities.
Access measures of success
In 2022, the first two applications to be jointly reviewed by all five members were approved: Asciminib (Scemblix®) for the treatment of Philadelphia chromosome-positive chronic myeloid leukemia, and Faricimab (Vabysmo®) to treat macular degeneration.8 These were approved through NASWSI in 2022 to 2023, which, as of June 2023, had approved 25 NAS work-sharing applications.9 As of December 18, 2024, the Access Consortium reported 26 medicines approved through the NASWSI.13
The consortium continues to look for new ways to streamline the review process and, in late 2023, the agencies created the Promise Pilot Pathway to create a common approach to the criteria for priority review. Promise applies to products that diagnose, treat or prevent a serious, life-threatening or severely debilitating condition and for which no other treatment is currently registered and marketed in participating regions.10
For the members of the consortium, who struggle with increased pressure on their resources and the added complexity from handling submissions for innovative medicines, collaboration can bring greater efficiencies. That in turn helps to bring innovative medicines to patients in need faster.4
Each module of the eCTD dossier, or in some cases designated sections within a module, is reviewed by a specific participating agency. Other agencies review the assessment report of each module, and a consolidated list of questions is sent out to the applicant for Modules 2 to 5.10 The country assigned to specific modules evaluates the responses and, if necessary, additional questions may be sent to the applicant for further clarification. Country-specific questions are treated on a national level.11 Each agency reviews its respective Module 1.10
Benefits of work-sharing for industry professionals
Work-sharing goals do help overburdened agencies, but they also help industry professionals. It is well understood that busy global pharmaceutical teams often struggle with competing deadlines. Being able to make one submission to multiple agencies reduces that burden, since teams only receive one lot of questions rather than different questions from each health authority on each module, often throughout the year, depending on the submission plan.
As one company found, taking a combination product through the Access pathway reduced the burden on their global teams, allowing them to focus on other priority projects and giving the company predictability about their internal resourcing needs.
Despite its benefits, it is also important to consider the approach carefully, since some authorities, such as the TGA, have rejected applications through Access for products approved in the EU, choosing instead to use other reliance or comparable overseas pathways. Furthermore, waiting for all participating countries to agree on the timelines can add time.
Nevertheless, given the significant resource burdens health authorities and companies alike face, synergies offered by Access to work-sharing can greatly benefit all stakeholders: regulators, industry and, most importantly, patients in need.
Selecting the right submission pathway for a product will depend on the markets involved and the company’s strategy.
Clause de non responsabilité :
Les informations fournies dans cet article ne constituent pas des conseils juridiques. Cencora, Inc. encourage vivement les lecteurs à consulter les informations disponibles relatives aux sujets abordés et à s’appuyer sur leur propre expérience et expertise pour prendre des décisions à ce sujet.
References
1. Access Consortium. "Access Consortium Strategic Plan 2021-2024."
2. Therapeutic Goods Administration. "Terms of Reference: Access Consortium.." March 20, 2024.
3. Therapeutic Goods Administration. "Therapeutic Goods Administration Performance Report 2024-25." 2026.
4. Therapeutic Goods Administration. "Information About the Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium.." March 25, 2025.
5. Therapeutic Goods Administration. "Access Consortium Offers Pipeline Meetings to Pharmaceutical and Biotechnology Companies.." May 16, 2023. Updated August 25, 2025.
6. DIA Global Forum. "Sharing the Regulatory Workload." March 2018.
7. Swissmedic. "New Work Sharing Initiative From the Access Consortium for Assessment of Biosimilar Applications." August 11, 2021.
8. Therapeutic Goods Administration. "International Work-Sharing: First Medicines Approved by All Five Access Consortium Regulators." September 2, 2022
9. Therapeutic Innovation & Regulatory Science. "Industry Perceptions and Experiences With the Access Consortium New Active Substance Work-Sharing Initiative (NASWSI): Survey Results and Recommendations." March 8, 2024.
10. Access Consortium. "Operational Procedures for the New Active Substance Work-Sharing Initiative (NASWSI), Version 1.2." June 1, 2025.
11. Therapeutic Goods Administration. "Access Consortium: New Active Substance (NAS) Work Sharing Initiative Questions and Answers (Q&A)." April 29, 2021.
12. Health Canada. "Access Consortium." September 14, 2026.
13. Access Consortium. "Access Consortium Strategic Plan 2025-2028."
