Access Consortium Strategic Plan 2021-2024

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Our vision is to provide faster access to safe, effective and high-quality medicines for all our populations.


Our mission is to align our regulations and policies to facilitate work-sharing on medicines and reduce duplication to ensure our populations have access to the health products they need for better health and well-being.


The Access Consortium is a collaborative initiative of the following governmental authorities that regulate human medicines and other health products:

The Consortium is committed to maximizing collaboration by:

This group originally consisted of the regulatory authorities in Australia, Canada, Singapore and Switzerland (previously referred to as ACSS). With the addition of the United Kingdom's Medicines and Healthcare products Regulatory Agency, a leading international medicines regulator, in October 2020, the Consortium changed its name to Access, reflecting the principal goal of increasing our populations' access to health products through international collaboration and work-sharing.

The Access Consortium now represents a collective population base of 150 million.


To help achieve the Consortium's mission, we continue to focus on enhancing our systems to enable work-sharing of applications for the registration of medicines containing new active substances, generics and biosimilar medicines.

To date, Access has successfully evaluated numerous new medicines and many more are under active review or assessment for work-sharing. Many Access sponsor applications include first-in-world medicines, with major medicines regulators performing the evaluation at the same time or only just ahead of the Access Consortium.

Regulatory innovation has become increasingly important as health products evolve, increase in complexity or are tailored to individual patients. Greater regulatory agility and international alignment by sharing of scientific resources and expertise, while at the same time maintaining independent regulatory decision-making within each authority, will reduce a product's time to a wider market. Exploring collaboration with national health technology assessment organizations (and similar) by Access countries also serves to improve patient access to safe and effective health products.

The COVID-19 pandemic triggered rapid regulatory innovation to address the urgent need for specific health products. Through agile regulatory processes, Access partners have collaborated to make these health products and medical supplies available. We now have an opportunity to build upon the learnings from COVID-19 and apply these agile practices to our work in Access.

The 2021-2024 Strategic Plan will guide us toward enhanced efficiency of our national regulatory systems, while optimizing synergies and alignment between regulatory authorities and reducing duplication for industry.

With our combined populations of 150 million, the Consortium aspires to be regulators of choice.

Strategic objectives

The following are the strategic objectives for 2021-2024 to guide the Access Consortium in achieving its vision and mission.

Strengthening Access work-sharing initiatives

Making Access a competitive and efficient submission pathway of choice for industry, supported by regulators:

Expanding lifecycle approach

Maximizing collaboration throughout the health product lifecycle:

Regulatory innovation that integrates a health care systems approach

Increasing regulatory capacity while collaborating with key national healthcare systems partners to facilitate uptake of innovative health products:

Indicators of success

The Access goal to become regulators of choice will be measured by the following indicators of success:

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