From 01 January 2021, pharmaceutical companies that submit applications to some or all of the five countries will benefit from having their products evaluated for marketing in those countries simultaneously with reduced evaluation times.
Drug developers have raised concerns about the potential effect of Brexit on patient access to new and critical medicines. In response, the Medicines and Healthcare products Regulatory Agency have joined the ACSS regulatory consortium which will be rebranded to ACCESS.
The UK population is almost as large as that of the four current ACSS members combined, meaning the involvement of MHRA will significantly increase the market accessible via the consortium. When the MHRA joins, ACCESS will cover a population of 145 million people.
The aim of ACCESS is to provide patients with timely access to high quality, safe and effective therapeutic products across the five countries. ACCESS partners will work together, aligning high standards of scientific rigour and integrity with reduced regulatory duplication.
The MHRA will become a full ACCESS member at the end of the transition period on 01 January 2021. The agency is also set to join the US Food and Drug Administration (FDA) Project Orbis on the same day.
For more information on ACCESS, click here.