UK’s MHRA Joins ACSS-Consortium, FDA’s Project Orbis

LONDON, United Kingdom – The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) is officially joining the Australia-Canada-Singapore-Switzerland (ACSS) Consortium on January 1, 2021. Before then, MHRA will shadow the Consortium.

The ACSS Consortium is a coalition of, as its founders note, “like-minded” regulatory authorities who work together to promote greater regulatory collaboration and alignment of regulatory requirements in order to provide patients timely access to high quality, safe, and effective therapeutic products.

The Consortium has so far successfully completed joint reviews of both innovative and generic medicines. Its work has piqued the interest of additional sponsors as well, all of whom intend to file through the Consortium’s collaborative pathway.

With the addition of the UK, the Consortium will update its guidance for the industry regarding applying for products for marketing authorization among Australia, Canada, Singapore, Switzerland, and the UK. This updated guidance will become available January 1, 2021.

As noted by MHRA, “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 with reduced evaluation times.”

Project Orbis Cross-Over

However, the ACSS Consortium is not a standalone organization, as it works with the U.S. Food and Drug Administration and, most recently, Brazil’s National Health Surveillance Agency (ANVISA) under Project Orbis, a collaborative initiative through the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs among the U.S., Canada, Australia, Switzerland, and Singapore.

Initially, Project Orbis involved only the U.S., Canada, and Australia, but shortly after its September 2019 launch, the Project was expanded to include the Consortium’s two other participating countries, Singapore and Switzerland.

Project Orbis allows for the simultaneous submission of applications for oncology products to the regulators of participating countries: The U.S. FDA, Brazil’s ANVISA, Health Canada, Australia’s Therapeutic Goods Administration (TGA), Singapore’s Health Sciences Authority (HSA), and Switzerland’s Swissmedic.

The FDA has approved a handful of drugs through Project Orbis, including, but not limited to, Roche’s Tecentriq (atezolizumab) plus Avastin (bevacizumab) for hepatocellular carcinoma (HCC), Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) plus Yervoy (ipilimumab) for non-small cell lung cancer (NSCLC), and, as of this week, Jazz’s Zepzelca (lurbinectedin) for NSCLC.

The FDA, Health Canada, and TGA have simultaneously reviewed medicines together before, as in the case of AstraZeneca’s (AZ) Calquence (acalabrutinib) for chronic lymphocytic leukemia (CLL). In addition, approvals have been granted in a relatively timely manner: Swissmedic approved Seattle’s Tukysa (tucatinib) for HER2+ breast cancer less than a month after the FDA, following concurrent submission through Project Orbis.

With the UK withdrawing from the European Union (EU), MHRA will become its sole drug regulator. The UK will soon be a lone wolf, once the Brexit transition period wraps, but through today’s announcement, it appears that the UK is remaining mindful of ensuring patient access in an environment where it will henceforth be relying entirely on its own policies. Already, the UK is a major market; teaming up with the Consortium and potentially Project Orbis positions the UK for continued regulatory power, specifically in the field of innovative medicines, while maintaining its own idiosyncrasies.

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