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Source: Australian Department of Health

The heads of the Australia-Canada-Singapore-Switzerland (ACSS) Consortium are pleased to announce that the United Kingdom (UK) therapeutic products regulator, the Medicines and Healthcare products Regulatory Authority (MHRA), is joining as a new member.

As one of the world’s leading regulators of therapeutic products, the MHRA will bring additional resources and expertise to this well-established collaboration group. The MHRA will officially commence working with consortium partners as a full member on 1 January 2021, with a period of shadowing before then.

The group has changed its name to accommodate the new partner, and will be known as the Access Consortium. The new name reflects the group’s key aim of providing patients with timely access to high-quality, safe and effective therapeutic products in 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 addition of the UK brings the combined population of countries participating in the consortium to about 145 million. Pharmaceutical companies that submit applications to some or all Access countries will benefit from having their products evaluated for marketing in those countries simultaneously, with reduced evaluation times.

To date, the consortium has successfully completed joint reviews of both innovative and generic medicines. It has received a significant number of expressions of interest from sponsors intending to file through our collaboration pathway.

Access will update the guidance for industry on how to apply to have products considered for marketing authorisation in the five member countries, including the UK. This guidance will be available on 1 January 2021.

The MHRA is delighted to be joining as this is a significant step for UK medicines regulation and for patient health. With the addition of the UK, Access will increase international cooperation and bring more timely access to medicines to an even larger population.