What is the ACCESS Consortium?

The ACCESS Consortium is an innovative regulatory collaboration between several countries' medicines and healthcare products regulatory agencies. It began in 2007 comprising of Therapeutic Goods Administration (TGA) of Australia, Health Canada (HC) of Canada, Health Sciences Authority (HAS) of Singapore, and Swissmedic of Switzerland. In 2021, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (UK MHRA) joined the ACCESS Consortium leading to proactive approach in harmonizing regulatory frameworks to reduce the time taken for safe, efficacious, and high-quality products reaching the market.

What is the objective and purpose of the ACCESS Consortium?

The consortium's primary objective is to provide a framework for the sharing of information and collaborative regulatory work, aimed at expediting the development, review, and approval processes of medicines, ensuring they are made available to the public in a timely manner without compromising on safety, efficacy, and quality.:

The consortium encompasses around 170 million individuals collectively. Members of the Access Consortium exchange information within a framework of bilateral confidentiality agreements and Memoranda of Understanding as they carry out their activities. Information is exchanged using a secure collaborative platform for document storage and management accessible only to authorized ACCESS members. While each regulatory authority maintains ultimate decision-making authority, efforts are made towards achieving harmonizations

The importance of the ACCESS Consortium lies in its ability to foster international cooperation and streamline the regulatory processes for pharmaceuticals. This is increasingly significant in a globalized world where diseases and health challenges do not recognize national borders. By collaborating, member countries can leverage their collective expertise, resources, and data, facilitating quicker access to vital medications. This is particularly crucial for addressing global health emergencies, such as pandemics, where the rapid approval and distribution of vaccines and treatments are essential. Furthermore, the consortium's work supports smaller markets, such as Singapore and Switzerland, by providing them with the regulatory heft that might otherwise be unavailable, ensuring their populations also have timely access to the latest healthcare innovations.

What are the Working Groups in ACCESS Consortium?

There are a number of working groups present within the ACCESS Consortium including New Active Substances Working Group, Generic Medicines Working Group, Biosimilars Working Group, Collaboration on ICH Working Group, IT Architecture Working Group, and most recently the Advanced Therapy Medicinal Products Working Group. Members of the Working Groups meet regularly to share insight and information regarding various regulatory challenges that the participating agencies face. These are related to marketing authorizations, clinical trials, site inspections, pharmacovigilance, development of technical/regulatory guidelines and collaboration.