The Medicines and Healthcare products Regulatory Agency (MHRA) is the latest regulator to join the Australia-Canada-Singapore-Switzerland (ACSS) Consortium.
To accommodate the MHRA joining the group will now be known as the Access Consortium.
The aim of the group is to provide patients with timely ‘access’ to high quality, safe and effective therapeutic products across the five countries. This is accomplished by Access partners working together, aligned by high standards of scientific rigour and integrity, with reduced regulatory duplication.
The MHRA will officially commence working with Consortium partners as a full member from the 01 January 2021 with a period of shadowing before then.
Pharmaceutical companies that submit applications to some or all of the five Access countries will benefit from having their products evaluated for marketing in those countries simultaneously with reduced evaluation times.
Access will update the guidance for industry on how to apply to have products considered for marketing authorization across the five-member countries, including the UK. The guidance will be available on 01 January 2021.