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 Agencystarted participating in work-sharing initiatives with consortiumpartners from 1 January 2021.
Access Growth Manifesto
To be a leading collaborative platform for the clinical development and regulatory submissions of your health products
Vision
To grow and advance regulatory cooperation and alignment to enable innovation, strengthen trust and accelerate access to safe, effective and high-quality health products to over 150 million patients across our member states
GROWTH – Our shared commitment
We aim to transform and shape a harmonised, trusted, forward-looking and patient-centric global regulatory ecosystem through close engagement and collaboration with the industry and its associations, where Access stands among the industries’ preferred filing pathways
Our GROWTH manifesto encompasses six core principles:
GOVERNANCE
Upholding scientific rigour and building collaborative platforms to strengthen regulatory trust and credibility
RELIANCE
Building confidence through shared assessment across product lifecycle to accelerate access and reduce duplication
OPENNESS
Communicating with transparency, clarity and shared purpose, reporting regularly on patient access outcomes
WORKSHARING
Collaborating across borders, aligning processes and exchanging expertise to enhance regulatory efficiency and coherence
TRANSFORMATION
Enabling innovation through digitalisation and forward-looking regulatory approaches
HARMONISATION
Sharing best practices to advance regulatory sciences, bridge regulatory and value-based reimbursement processes, to deliver timely patient outcomes
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.
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.
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:
Please see here for a list of products approved under the New Active Substance and Generic Medicine collaborative authorisation procedures.
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 AccessConsortium
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.
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