MHRA joins international regulatory consortium

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium of regulatory bodies. To accommodate the MHRA, the group will now be called the Access Consortium.

The Access Consortium aims to provide patients with timely access to high quality, safe and effective therapeutic products across the five countries. To accomplish this, the agencies work together using high standards of scientific rigour and integrity to reduce regulatory duplication.

According to the consortium, the MHRA will bring additional resources and expertise to the group and will officially begin collaborating as a full member on the 1 January 2021 with a period of shadowing prior to this date.

The MHRA stated that the with the UK, the combined population of the participating countries is approximately 145 million. According to the UK regulator, 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.

The agency added that the consortium has successfully completed joint reviews of both innovative and generic medicines to date and has received a significant number of additional expressions of interest from sponsors intending to file through the collaborative pathway.

Access will update their guidance on how to apply to have products considered for marketing authorisation across the five member countries and make this available on 1 January 2021.