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Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium
The TGA is part of the Access Consortium along with:
- Health Canada
- Health Sciences Authority of Singapore
- Swissmedic, Swiss Agency for Therapeutic Products, and
- MHRA, UK Medicines and Healthcare products Regulatory Agency.
The Access Consortium is a medium-sized 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 United Kingdom regulator - the Medicines and Healthcare products Regulatory Agency (MHRA) - joined, and the group's name was changed to 'Access'. The MHRA will commence work-sharing applications with Access partners from 1 January 2021.
The 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 Access Consortium explores opportunities for information and work-sharing in areas including:
- generic medicines registration
- assessment reports for new prescription medicines
- information sharing and investigations into post-market medicine safety
- alignment of IT systems for information sharing
- development of technical guidelines.
The trend towards globalisation of therapeutic products 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 Terms of Reference for the Access Consortium were updated in September 2020 and will be reviewed and approved annually by the heads of Access agencies or as necessary./p>
Access heads of agencies
The heads of the five agencies meet twice annually in the margins of international meetings or conferences to review progress of the Access working groups and approve the work program for the upcoming year.
Access working groups
Currently, the Access Consortium has a number of active working groups in place, such as the Access Generic Medicines Working Group, the Access New Active Substances/Benefit-Risk Working Group, the Access Complementary Health Products Working Group, and the Access IT Architecture Working Group.
Access Consortium working group members have teleconferences and meetings on a regular basis to exchange information on regulatory issues and challenges faced by participating regulatory agencies.
Access New Active Substance (NAS) Work Sharing Initiative
The New Active Substance Work Sharing Initiative, previously known as the New Chemical Entities Working Group, has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. By engaging in these partnerships, Access is able to reduce regulatory duplication, and increase each agency's capacity to ensure consumers have timely access to high quality, safe and effective therapeutic products.
- See the links below for more information regarding the work-sharing pilot (including useful links), frequently asked questions and the logistical framework for work-sharing submissions
- Applications that have successfully received market approval through this initiative include:
Access Generic Medicines Working Group
- The Generic Medicines Working Group has been active since 2012, and is one of the more established and advanced initiatives under the Access Consortium umbrella.
- It is creating opportunities and benefits for regulatory programmes through:
- greater alignment of regulatory approaches and technical requirements;
- more efficient use of resources through information and work sharing;
- the establishment of an effective network among trusted, like-minded regulatory authorities; and
- the establishment of the Generic Medicines Work Sharing Trial
This working group operates under a rotating chair arrangement.
The GMWG Mandate was endorsed in April 2018.