UK medicines regulator joins ACSS consortium of regulators

UK medicines regulator joins ACSS consortium of regulators
© iStock/AlexRaths.

The UK medicines regulator, Medicines and Healthcare products Regulatory Agency (MHRA) has now joined the Australia-Canada-Singapore-Switzerland (ACSS) Consortium.

The ACSS Consortium will now be known as the Access Consortium and the MHRA will officially commence working with Consortium partners as a full member from 1 January 2021 with a period of shadowing beforehand.

The aim of the group is to provide patients with timely access to high quality, safe, and effective therapeutic products across the five countries.

International collaboration

The MHRA is one of the world’s leading regulators of therapeutic products and will bring additional resources and expertise to the collaboration group. The addition of the UK brings the combined population of countries participating in the Consortium to approximately 145 million.

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 resulting in reduced evaluation times.

The Consortium has already successfully completed joint reviews of both innovative and generic medicines. It has also received a significant number of additional expressions of interest from sponsors intending to file through the collaborative pathway that now will include the UK.

Access will update the guidance for the industry on how to apply to have products considered for marketing authorisation across the five member countries, which will be available on when the UK officially joins the consortium on 1 January 2021.

The Access Consortium regulators welcome the UK into the partnership, it says, and the MHRA notes that it is delighted to be joining – highlighting that this is a significant step for UK medicines regulation and for patient health.

The Access Consortium will increase international co-operation and bring more timely access to medicines to an even larger population.

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