Welcome to the Access Consortium

Coordinated regulation ensuring patient access to high quality, safe and effective products

The Access Consortium is a coalition of like-minded regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements.

The original consortium, formed in 2007 and known as “ACSS”, comprised the national regulatory authorities of Australia, Canada, Singapore and Switzerland. In October 2020, the UK joined, and the group’s name was changed to “Access”. The UK’s Medicines and Healthcare products Regulatory Agency started participating in work-sharing initiatives with consortium partners from 1 January 2021.

Our goal

Our main goal is to maximise international co-operation between partners in the Access consortium, reduce duplication, and increase each agency’s capacity to ensure patients have timely access to high quality, safe and effective therapeutic products.

The trend towards globalisation of therapeutic products industries and the rapid emergence of new technologies in the last decade accompanied with shared global challenges have created an increased need for regulatory bodies to co-operate and communicate with each other routinely. To address this, we maximise the use of up-to-date technical expertise, and ensures a consistent, contemporary approach to assessing the benefits and risks associated with the use of therapeutic products.

Our members

Access Strategic Plan 2025-2028

Our strategy

The Access Consortium is pleased to present our updated strategic plan, which outlines our approach to regulatory collaboration for the coming years.

Our vision remains focused on enhancing cooperation amongst member countries to streamline procedures and improve access to safe, effective medicines. We aim to create an environment that benefits patients, industry partners, and regulatory bodies alike.

The renewed plan emphasises solidifying our collaborative processes, aligning expectations with industry, and improving our communication strategies. We're introducing a new cloud-based workspace to facilitate joint reviews, which we believe will enhance our efficiency.

Our key strategic objectives are:

Strengthening work-sharing initiatives
Expanding our lifecycle approach
Supporting regulatory innovation
Enhancing stakeholder engagement

We continue to encourage joint applications, particularly those involving all member countries, as these offer the greatest collaborative benefits.

Access Strategic Plan 2025-2028

Our ways of working

Heads of Agencies meetings

The heads of the five member agencies act as the steering committee for the Access Consortium. Meeting twice a year, the Heads of Agencies review progress of the Access Consortium working groups and approve the work program for the upcoming year.

Access working groups, subgroups and networks

Members of the different Access Consortium working groups meet regularly to exchange information on regulatory challenges faced by the participating regulatory agencies.

Topics discussed by consortium members include clinical trials, marketing authorisations, product manufacturing site inspections, post-marketing surveillance, joint development of technical guidelines or regulatory standards, and collaboration on information platforms.

Access Consortium strategic plan 2021-2024 details the key activities to be delivered in these areas. subgroups help to drive forward agreed activities and Access Consortium informal networks have been established for the ongoing exchange and sharing of information.

Currently, the Access Consortium has the following working groups, subgroups and networks in place:

Working groups and subgroups

New Active Substances Working, including the PROMISE subgroup
Generic Medicines Working Group
Advanced Therapy Medicinal Products Working Group
Clinical Trials Working Group
IT Architecture Working Group

Networks

Biosimilars network
Complementary Health Products network
Good Manufacturing Practice network
Access ICH Collaboration network

Work Sharing Procedures

Access Consortium work sharing procedures build synergies and share knowledge amongst the regulatory authorities to provide faster patient access to safe, effective and high-quality medicines.

The Access Consortium has developed the following collaborative authorisation procedures:

New Active Substance Work Sharing Initiative
Generic Medicine Work Sharing Initiative

Joint Pipeline Meetings

The ACCESS Consortium offers joint pipeline meetings to pharmaceutical and biotechnology companies. These meetings present an opportunity to exchange information on new developments and to collaborate on new possibilities. They also help Access regulators plan and prepare for future work-share applications.

Statements from the Access Consortium

Periodically, the ACCESS Consortium develops and publishes statements of intent from the membership. These statements are not intended to create legal obligations of any nature, either in domestic or international law, nor are they intended to diminish or otherwise affect the authority of ACCESS Consortium members to carry out their responsibilities and regulatory programmes. The following statements have been published by the ACCESS Consortium to date:

Access Consortium Good Manufacturing Practice (GMP) Statement

The Access Consortium Statement on Good Manufacturing Practice (GMP) Inspections Reliance and Recognition was endorsed in November 2022.

Read the Access Consortium Good Manufacturing Practice (GMP) Statement

Access Consortium statement on COVID-19 medicines

The Access Consortium statement on COVID-19 medicines was endorsed in December 2021.

Read the Access Consortium statement on COVID-19 medicines

Access Consortium statement on COVID-19 vaccines evidence

The Access Consortium statement on COVID-19 vaccines evidence was endorsed in January 2021.