Access Consortium

Swissmedic is part of the Access Consortium, along with:

The Access Consortium is a collaborative initiative of like-minded, medium-sized regulatory authorities between Australia's Therapeutic Goods Administration (TGA), Health Canada (HC), Singapore's Health Sciences Authority (HSA), the Swiss Agency for Therapeutic Products (Swissmedic) of Switzerland and the Medicines and Healthcare products Regulatory Authority(MHRA) of the United Kingdom1. Regulatory authorities face very similar challenges, such as increasing workload and increasing complexities in the medicinal applications that are being regulated, thus contributing to increasing pressure on available resources. The purpose of the consortium is to build synergies and share knowledge amongst the regulatory authorities thereby enhanced efficiency of regulatory systems.

The Access Consortium consists of several working groups with various objectives and projects that aim to help meet the challenges faced by regulatory authorities, including timely access to safe therapeutic products within a limited resource capacity. The working groups use a network of bilateral confidentiality agreements and Memoranda of Understanding to conduct their work.

The Consortium explores opportunities for information and work-sharing initiatives in areas including2:

  • assessing therapeutic product manufacturing sites
  • post-market surveillance of therapeutic product safety
  • assessment reports for medicinal products
  • development of technical guidelines and regulatory standards
  • collaboration on information technology (IT)

1The MHRA will officially commence working with Consortium partners as a full member from 1 January 2021, with a period of shadowing before then.

2Exchange of confidential information is consistent with the provisions of existing agreements and compliant with each agency's legislative framework for sharing such information with other regulatory authorities.

https://www.swissmedic.ch/content/swissmedic/en/home/about-us/international-collaboration/multilateral-co-operation-with-international-organisations---ini/multilateral-co-operation-with-international-organisations---ini.html