Abstract

The Access Consortium, comprising regulatory authorities from Australia, Canada, Singapore, Switzerland, and the United Kingdom, is a pivotal collaborative framework aimed at enhancing global access to safe, effective, and high-quality therapeutic products. Established in 2007 as the ACSS Consortium and rebranded in 2020 with the inclusion of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the consortium fosters regulatory convergence through work-sharing, harmonized standards, and expertise exchange. Its Strategic Plan for 2025–2028 emphasizes streamlined processes, technological advancements like a cloud-based workspace, and focused initiatives on new active substances, biosimilars, and advanced therapy medicinal products (ATMPs). By reducing duplication and aligning regulatory practices, the consortium accelerates patient access to innovative medicines while maintaining rigorous safety and efficacy standards. This article explores the consortium’s origins, structure, key initiatives, challenges, and future directions, highlighting its role in shaping efficient global regulatory systems.

The Access Consortium: Advancing Global Regulatory Collaboration for Timely Access to Safe and Effective Medicines

Introduction

In an era of increasing globalization and rapid advancements in therapeutic product development, regulatory authorities face mounting challenges, including growing workloads, complex scientific evaluations, and resource constraints. The Access Consortium, a coalition of medium-sized, like-minded regulatory authorities, has emerged as a pivotal force in addressing these challenges through international cooperation, work-sharing, and regulatory alignment. Established to streamline processes, reduce duplication, and enhance patient access to high-quality, safe, and effective medicines, the Access Consortium exemplifies a model of global regulatory collaboration. This article explores the origins, objectives, structure, initiatives, and future directions of the Access Consortium, drawing on information from its official website and guidance provided by its member states.

 

Origins and Evolution of the Access Consortium

The Access Consortium was initially formed in 2007 as the Australia-Canada-Singapore-Switzerland (ACSS) Consortium, comprising the national regulatory authorities of Australia (Therapeutic Goods Administration, TGA), Canada (Health Canada), Singapore (Health Sciences Authority, HSA), and Switzerland (Swissmedic). The coalition aimed to foster regulatory convergence and share expertise to address scientific and regulatory challenges collaboratively. In October 2020, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) joined the group, prompting a rebranding to the “Access Consortium” to reflect its expanded membership and renewed focus on enhancing access to therapeutic products.

The inclusion of the MHRA, effective from January 1, 2021, marked a significant milestone, enabling the consortium to leverage the UK’s regulatory expertise and further strengthen its collaborative framework. The consortium’s evolution reflects the growing need for regulatory bodies to cooperate routinely in response to the globalization of the pharmaceutical industry and the emergence of innovative technologies, such as advanced therapy medicinal products (ATMPs).

 

Objectives and Strategic Vision

The Access Consortium’s primary goal is to maximize international cooperation among its member agencies to reduce duplication, align regulatory systems, and increase each agency’s capacity to ensure timely patient access to high-quality, safe, and effective therapeutic products. By fostering synergies and sharing knowledge, the consortium aims to streamline regulatory processes while maintaining rigorous standards for safety, efficacy, and quality.

The Access Consortium’s Strategic Plan for 2025–2028 outlines its vision to enhance cooperation among member countries, streamline procedures, and improve access to safe and effective medicines. The plan emphasizes solidifying collaborative processes, aligning expectations with industry stakeholders, and improving communication strategies. A key initiative is the introduction of a cloud-based workspace to facilitate joint reviews, which is expected to enhance efficiency and foster greater collaboration. The consortium encourages joint applications, particularly those involving all member countries, as these offer the greatest collaborative benefits.

The consortium operates on principles of respect, transparency, openness, flexibility, equality, and resource equity. Each member agency has equal status in decision-making and may opt out of specific activities due to regulatory or resource constraints. This flexible approach ensures that the consortium remains adaptable to the diverse needs of its members while pursuing common goals.

 

Structure and Governance

The Access Consortium is steered by the heads of its five member agencies, who form the Heads of Agencies (HoA) Steering Committee. The HoA meets at least twice annually, often in conjunction with international meetings such as the DIA Annual Meeting or the Summit of Heads of Medicines Regulatory Agencies. Additional teleconferences are held as needed to review progress, approve work programs, and set strategic directions.

The consortium operates through various working groups, subgroups, and informal networks that focus on specific regulatory areas. These include:

  • New Active Substances (NAS) Work-Sharing Initiative (NASWSI): Facilitates joint reviews of applications for new active substances to accelerate approvals.
  • Generic Medicines Working Group (GMWG): Focuses on harmonizing regulatory requirements for generic medicines.
  • Biosimilars Work-Sharing Initiative: Supports collaborative reviews of biosimilar applications.
  • Advanced Therapy Medicinal Products (ATMPs) Working Group: Established in 2023, this group addresses regulatory challenges related to cell therapies, gene therapies, and tissue engineering products.
  • Collaboration on International Council for Harmonisation (ICH): Coordinates the involvement of technical experts in ICH working groups to align with global standards.
  • IT Architecture: Explores technological solutions to enhance regulatory collaboration.
  • Good Manufacturing Practice (GMP) Inspections Reliance and Recognition: Promotes mutual recognition of GMP inspections to reduce duplication.

These working groups meet regularly to exchange information on regulatory challenges, such as clinical trials, marketing authorizations, manufacturing site inspections, and post-marketing surveillance. They also develop technical guidelines and regulatory standards collaboratively. Participation in these groups is voluntary, and chair responsibilities are distributed equitably among members to ensure balanced contributions.

Confidential information is shared among members through secure platforms, such as SharePoint, ensuring efficient and secure communication. The consortium avoids duplicating efforts with other international mechanisms, focusing instead on complementary initiatives that enhance regulatory efficiency.

Key Initiatives and Achievements

Work-Sharing Initiatives

The Access Consortium’s work-sharing initiatives are central to its mission of reducing regulatory duplication and accelerating patient access to medicines. The New Active Substances Work-Sharing Initiative (NASWSI), launched in 2018, allows member agencies to jointly review applications for new active substances. A 2021 survey by Innovative Medicines Canada found that 80% of pharmaceutical companies participating in NASWSI cited motivations such as predictable timelines and the potential for near-simultaneous approvals in multiple markets. While affiliates reported positive experiences, some noted challenges, such as the complexity of coordinating submissions across jurisdictions. Recommendations to improve NASWSI include enhancing predictability, transparency, and harmonization while maintaining flexibility.

The Generic Medicines and Biosimilars Work-Sharing Initiatives similarly aim to streamline reviews by leveraging shared expertise. These initiatives have been particularly valuable in addressing the increasing complexity of generic and biosimilar products, ensuring consistent regulatory standards across member countries.

 

Advanced Therapy Medicinal Products (ATMPs)

In 2023, the Access Consortium established a dedicated ATMP Working Group to address the unique regulatory challenges posed by cell therapies, gene therapies, and tissue engineering products. The group fosters interdisciplinary discussions on quality, non-clinical, and clinical aspects, focusing on risk-benefit assessments and regulatory decision-making. It also explores opportunities for work-sharing, reliance, and joint scientific advice, aiming to publish harmonized guidance on ATMPs. This initiative reflects the consortium’s commitment to keeping pace with emerging therapeutic innovations.

 

Good Manufacturing Practice (GMP) Inspections

The Access Consortium’s Statement on Good Manufacturing Practice (GMP) Inspections Reliance and Recognition, endorsed in November 2022, promotes mutual recognition of GMP inspections among member agencies. This reduces the need for duplicate inspections, saving resources and enhancing efficiency. All members align with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) standards, ensuring consistency in GMP requirements.

 

COVID-19 Response

The Access Consortium played a significant role during the COVID-19 pandemic, issuing guidance on modifications to COVID-19 vaccines to address new variants and confirming the suitability of immunobridging studies for vaccine authorizations. These efforts demonstrated the consortium’s ability to respond rapidly to global health challenges through coordinated regulatory actions. The consortium also facilitated the rapid review and authorization of several COVID-19 treatments and vaccines through information sharing among its members.

 

Pipeline Meetings

The consortium offers joint pipeline meetings to pharmaceutical and biotechnology companies, providing opportunities to exchange information on new developments and plan for future work-sharing applications. These meetings enhance collaboration between regulators and industry, aligning expectations and improving submission quality.

 

Challenges and Opportunities

Despite its successes, the Access Consortium faces challenges in achieving its objectives. Industry feedback highlights perceived barriers to participation, such as the complexity of coordinating multi-jurisdictional submissions and a lack of clear incentives, such as guaranteed shorter review timelines or reduced fees. Concerns also exist regarding alignment on priority reviews and technical requirements among member agencies. To address these, the consortium has issued operational procedures for NASWSI and is exploring ways to enhance predictability, transparency, and harmonization.

The introduction of a cloud-based workspace represents a significant opportunity to improve efficiency by facilitating real-time collaboration on joint reviews. Additionally, the consortium’s focus on ATMPs positions it to lead in regulating cutting-edge therapies, fostering innovation while ensuring patient safety.

Another opportunity lies in expanding the scope of work-sharing to include post-market activities, such as pharmacovigilance and lifecycle management, which would create a more integrated regulatory approach

 

Future Directions

The Access Consortium’s Strategic Plan for 2025–2028 sets an ambitious agenda to further strengthen regulatory collaboration. Key priorities include:

  • Enhancing Work-Sharing: Expanding the scope and uptake of work-sharing initiatives to cover more product types and regulatory processes.
  • Leveraging Technology: Fully implementing the cloud-based workspace to streamline joint reviews and improve data sharing.
  • Harmonizing Standards: Developing and publishing harmonized guidance, particularly for ATMPs and other innovative therapies.
  • Strengthening Industry Engagement: Increasing transparency and communication with industry stakeholders to encourage participation in joint applications.
  • Global Alignment: Deepening collaboration with international bodies, such as the ICH, to align with global regulatory standards.

By pursuing these priorities, the Access Consortium aims to create an environment that benefits patients, industry partners, and regulators alike, ensuring faster access to innovative medicines without compromising safety or quality.

 

Conclusion

The Access Consortium stands as a model of international regulatory collaboration, uniting five medium-sized regulatory authorities to address shared challenges and enhance patient access to safe and effective medicines. Through its work-sharing initiatives, strategic vision, and commitment to innovation, the consortium has made significant strides in reducing regulatory duplication and fostering harmonization. As it continues to evolve, the Access Consortium is well-positioned to navigate the complexities of modern therapeutic product regulation, delivering tangible benefits to patients and stakeholders worldwide.

This article was written by:

Shailly Garg
CMC specialist | ProductLife Group

Supported by:

Fabio Pedna
Team Lead | ProductLife Group

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The Access Consortium: Advancing Global Regulatory Collaboration for Timely Access to Safe and Effective Medicines