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.