皇冠体育app

皇冠体育app consortium is a medium-sized coalition of regulatory authorities that work together to promote greater regulatory collaboration and alignment of regulatory requirements.

皇冠体育app original consortium, formed in 2007 and known as 鈥楢CSS鈥�, comprised the national regulatory authorities of Australia, Canada, Singapore and Switzerland. In October 2020, the MHRA joined, and the group鈥檚 name was changed to 鈥楢ccess鈥�. 皇冠体育app MHRA commenced work-sharing applications with Access partners from 1 January 2021.

皇冠体育app consortium鈥檚 goal is to maximise international co-operation between partners in the consortium, reduce duplication, and increase each agency鈥檚 capacity to ensure patients have timely access to high quality, safe and effective therapeutic products.

皇冠体育app 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.

Access heads of agencies

皇冠体育app 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.

Access Strategic Plan 2021-2024

皇冠体育app Access Consortium heads of agencies have developed the Access Strategic Plan for 2021-2024. This plan will guide us toward enhanced efficiency of our national regulatory systems, while optimising synergies and alignment between regulatory authorities and reducing duplication for industry.

(PDF, 517 KB, 4 pages)

Access Consortium Good Manufacturing Practice (GMP) Statement

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

Access Consortium GMP statement

Access working groups

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
• Collaboration on International Council for Harmonization (ICH) Working Group
• IT Architecture Working Group
• Advanced 皇冠体育apprapy Medicinal Products 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.

View the Access Consortium Generic Medicines Working Group Mandate.

Advanced 皇冠体育apprapy Medicinal Products Working Group

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.

皇冠体育app 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

Work Sharing Procedures

皇冠体育app Access consortium has developed 3 authorisation procedures: the New Active Substance and Biosimilar Work Sharing Initiatives and the Generic Medicine Work Sharing Initiative.

Joint Pipeline Meetings

皇冠体育app Access Consortium is offering joint pipeline meetings to pharmaceutical and biotechnology companies. 皇冠体育appse meetings will present an opportunity to exchange information on new developments and collaborate on new possibilities. 皇冠体育appy also help Access regulators plan and prepare for future work-share applications.

Additional information

Information regarding the Access consortium can be found:

皇冠体育apprapeutic Goods Administration of Australia (TGA):

Health Canada:

Swissmedic:

Health Science Authority:

For queries or to submit an Expression of Interest form, please contact [email protected].