News about GMP/cGMP


British MHRA becomes new member of the ACSS Consortium

The ACSS Consortium, a joint initiative of the regulatory authorities of Australia (TGA), Canada (HC), Singapore (HSA) and Switzerland (Swissmedic) announces a new membership: the British MHRA. Following as short observatory role, the MHRA will officially start to work with the consortium partners on January 1, 2021.Along with this, the group has changed its name to accommodate the new partner, and will be known as the "Access Consortium". The new name reflects the group’s key aim of providing patients with timely ‘access’ to high quality, safe and effective therapeutic products across the five countries.

What is the purpose of the Access Consortium?

The individual regulatory authorities face very similar challenges, in particular a growing volume of work and increasingly complex cases for regulated medicines. Within the consortium, the member authorities can pool their resources and exploit synergies. Knowledge can be exchanged and thus regulatory systems can be more efficient.

The MHRA is expected to contribute further resources and additional expertise. With the participation of the United Kingdom, the total population of all countries participating in the consortium now comprises around 145 million people.

What are the advantages for pharmaceutical manufacturers?

Pharmaceutical companies submitting a marketing authorization application in several or all five countries of the consortium will benefit from the simultaneous assessment of the application in these countries and reduced assessment times. The Access Consortium is currently revising its industry guide for the submission of marketing authorization applications to all five member countries including the UK. The guide will be available from 1 January 2021.