The MHRA is joining the ACSS Consortium, and will begin working with regulators from Australia, Canada, Singapore and Switzerland on 1 January 2021


The MHRA regulates medical devices, therapeutics and all other healthcare-related products in the UK (Credit: MHRA)

The MHRA (Medicines and Healthcare products Regulatory Agency) has joined the ACSS consortium with regulators in Australia, Canada, Singapore and Switzerland.

The group – which will now be known as the Access Consortium – aims to provide patients with more timely safe and effective therapeutic products across the five countries in the future.

Companies that submit applications to any of the regulatory agencies in these areas will benefit from having their products assessed for marketing in all five countries simultaneously with reduced evaluation times, according to the MHRA.

Following the addition of the UK regulator to the consortium, the combined population of the participating territories is close to 145 million.

The MHRA will officially begin working with its new consortium partners as a full member from 1 January 2021 – with a period of “shadowing” taking place before then.


The consortium formerly known as ACSS

Having previously only been made up of regulatory bodies from Australia, Canada, Singapore and Switzerland, the group was simply known as the ACSS Consortium.

Specifically, it consisted of the Australian TGA (Therapeutic Goods Administration), Health Canada, the Health Sciences Authority (HSA) of Singapore, and Swissmedic.

The original consortium was formed in 2007 with the intention of improving regulatory collaboration and international cooperation, aligning regulatory requirements, and raising the standards of scientific rigour and integrity while reducing regulatory duplication in its member countries.

Pharmaceutical products that have successfully received market approval through the ACSS Consortium in the past include prostate cancer drug Nubeqa, influenza medication Xofluza, and Vyndamax and Vyndaqel – the first therapeutics ever to be approved for treating a rare cause of heart failure called transthyretin amyloid cardiomyopathy.

As one of the world’s leading regulatory bodies for therapeutic products such as these, the MHRA said it will now bring “additional resources and expertise” to a well-established collaboration group.