Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium
Information about the Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium
Access members
The TGA is a member of the Access Consortium along with Health Canada, Health Sciences Authority of Singapore, Swissmedic and the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
The Access Consortium is a medium-sized coalition of 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 MHRA joined and the group's name was changed to the 'Access Consortium'. The MHRA will commence work-sharing applications with Consortium partners from 1 January 2021.
Access goals and mission
The trend towards globalisation of therapeutic product industries and the rapid emergence of new technologies have created an increased need for regulatory bodies to communicate with each other routinely. This maximises 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.
The Access Consortium Strategic Plan 2021-2024 was endorsed by the five regulatory authorities and published in June 2021.
The Access Consortium's goal is to maximise international cooperation, reduce duplication, and increase each agency's capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products.
The Consortium explores opportunities for information and work-sharing in areas including:
- the registration of medicines containing new active substances (including COVID-19 vaccines and therapeutics)
- the registration of generic and biosimilar medicines
- post-market medicine safety information
- development of technical guidelines for industry
- alignment of IT systems and architecture.
Access heads of agencies
The heads of the five agencies meet twice annually face to face in the margins of international meetings or conferences and also via teleconferences to review progress of the Access Consortium working groups and approve the work program for the upcoming year.
The Terms of Reference for the Access Consortium were updated in November 2023 and will be reviewed and approved annually by the heads of Access agencies or as necessary.
Access offers pipeline meetings
The Access Consortium is offering joint pipeline meetings to pharmaceutical and biotechnology companies.
Access Statement on Good Manufacturing Practice
The Access Consortium Statement on Good Manufacturing Practice (GMP) Inspections Reliance and Recognition was endorsed in November 2022.
Access work sharing initiatives
The Access Consortium continues to serve as a ‘testing ground’ for new and innovative collaborative approaches and can act as a pilot forum for larger international initiatives. The purpose of work-sharing is to build synergies and share knowledge amongst the regulatory authorities to provide faster patient access to safe, effective and higher quality medicines.
Although it is anticipated that a joint review may lead to the same decision, each regulator will maintain its independence for decision making.
Access work-sharing offers sponsors:
- Streamlined process - internationally coordinated review to reduce duplication and burden
- Increased access - possibility of simultaneous access to markets of multiple countries
- Flexibility - adaptability in how regulators organise collaboration amongst each other on a given review and which countries a company chooses to submit applications
- Predictability - pre-determined milestones and targeted review timeframes
The links below provide further information for sponsors regarding work-sharing initiatives and frameworks for submissions:
- Access Consortium Generic Medicines work-sharing initiative
- Access Consortium New Active Substances (NAS) work-sharing initiative
- Access Consortium Biosimilars work-sharing initiative
Access working groups
Access Consortium working group members attend teleconferences and, where possible, face-to-face meetings on a regular basis to exchange information on regulatory issues and challenges faced by participating regulatory agencies.
Currently, the Access Consortium has a number of active working groups in place including the:
Generic Medicines Working Group (GMWG) has been active since 2012 and is one of the more established and advanced initiatives under the Access umbrella. This group is creating opportunities and benefits for regulatory programmes through:
- greater alignment of regulatory approaches and technical requirements,
- efficient use of resources through information and work sharing, and
- establishment of an effective network among trusted, like-minded regulatory authorities.
Please see the GMWG Mandate for more information.
The New Active Substances Working Group (NASWG) coordinates the New Active Substance work-sharing initiative. This unique global collaboration involves the joint review of innovative medicines including new chemical entity or new biological entity applications, or new indication applications.
This initiative continues to foster cooperation and strong relationships between its Access partners.
The COVID-19 Vaccines & Therapeutics Working Group (CVTWG) meet regularly to share information and discuss COVID-19 vaccine regulatory issues as they arise.
In December 2020, Access released information regarding the regulatory evidence requirements for COVID-19 vaccine authorisations and considerations for post-market pharmacovigilance which built on the Consortium's pledge to work together to counter the COVID-19 global pandemic.
In March 2021, Access released new guidance clarifying the information required by medicine regulators to approve any modifications to authorised COVID-19 vaccines should virus mutations make them less effective at preventing the disease.
In September 2021, Access Consortium issued a joint statement confirming the suitability of appropriately designed immunobridging studies as an acceptable approach to authorising COVID-19 vaccines.
In 2023, the Access Consortium established a working group for advanced therapy medicinal products (ATMPs). ATMP is a term used in the legislative framework implemented by the European Union to regulate cell therapies, gene therapies and tissue engineering products.
The main goals of this group are to:
- foster interdisciplinary (quality, non-clinical, clinical) scientific discussions on emerging innovative therapeutic concepts and technologies
- establish an interdisciplinary forum for Access members to discuss ATMP-specific topics with a focus on assessing benefits and risks and on regulatory decision-making
- encourage mutual exchange and harmonization on the regulatory assessment of ATMPs
- explore potential synergies and opportunities for work-sharing, reliance and providing joint scientific advice
- publish guidance and recommendations on common areas where the group has established a harmonized approach, where appropriate
The Biosimilars Working Group (BSWG) was established on an interim basis in October 2017. It held its first teleconference in January 2018. Swissmedic provided the inaugural Chair, with the current Chair from the TGA.
The objectives of the BSWG include enabling the members to exchange regulatory evaluation information, conduct joint assessments of biosimilar applications for marketing authorisation, and to discuss any emerging regulatory issues with biosimilar medicinal products.
The Complementary Health Products Working Group (CHPWG) is a less formal network of participants who share information on the safety, quality and efficacy of complementary health products. The goals of this working group are to enable member authorities to exchange regulatory evaluation information on Complementary Health Product (CHP) ingredients; to conduct joint safety assessment of CHP ingredients; and to discuss emerging regulatory issues with CHP.
The objective of the Information Technology (IT) Working Group's priorities are to establish a secure platform for the exchange of confidential business information and share information on IT architecture, planned activities and ongoing projects.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Collaboration (ICH) Working Group supports the ICH’s goal of international harmonisation of guidelines on topics relating to pharmaceuticals for human use. This collaborative arrangement capitalises on each agency’s area of strength, while addressing gaps in science, knowledge, and expertise. As many regulators participate in the development of ICH guidelines, this working group provides an effective and efficient alternative to participating independently on all ICH topics.