Today we’re focusing on the Access Consortium. 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. 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.
What is the Access Consortium?
The consortium is a medium-sized coalition of regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements.
Which regulatory authorities are involved?
The consortium comprises the national regulatory authorities of:
- Australia – Therapeutic Goods Administration of Australia (TGA): Access Consortium
- Canada – Health Canada: Access Consortium
- Singapore – Health Science Authority: Access Consortium
- Switzerland – Swissmedic: Access Consortium
- UK* – MHRA: Access Consortium
*Joined October 2020
What is the aim of the consortium?
The consortium’s goal is to maximise international co-operation between partners in the consortium, reduce duplication, and increase each agency’s capacity to ensure patients have timely access to high quality, safe and effective therapeutic products.
How does the consortium work?
Currently, the Access Consortium has a number of working groups in place including the:
- New Active Substances Working Group
- Generic Medicines Working Group
- Biosimilars Working Group
- Complementary Health Products Working Group
- Collaboration on International Council for Harmonization (ICH) Working Group
- IT Architecture Working Group
Access Consortium working group members have regular meetings to exchange information on regulatory issues and challenges faced by the participating regulatory agencies including issues on clinical trials, marketing authorisations, product manufacturing site inspections, post-marketing surveillance, joint development of technical guidelines or regulatory standards, and collaboration on information platforms.
What are the work sharing procedures?
The Access consortium has developed 2 authorisation procedures:
- the New Active Substance Work Sharing Initiative
- the Generic Medicines Work Sharing Initiative
How often does the consortium meet?
The heads of the five agencies usually meet twice a year face-to-face 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.
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