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The following text was first published on 15 October 2020:

On 14 October, the UK Government formally announced that it will join Project Orbis. A programme coordinated by the US Food and Drug Administration involving Canada, Australia, Switzerland, Singapore and Brazil to review and approve promising cancer treatments.

The UK’s decision to take part in Orbis demonstrates the kind of regulatory autonomy that many have been calling for post-Brexit. So far, the European Medicines Agency has distanced itself from the initiative.

Orbis could lead to shorter regulatory timeframes, as evidenced in Canada. However, such benefits are not guaranteed in what is still a rather informal initiative with unclear processes.

Successful or not, the UK’s involvement with Orbis could be just one of many innovative mechanisms that the UK capitalises upon to reshape its medicines and medical devices regulatory landscape. The Government simultaneously announced that it would be joining the Access Consortium, a programme involving Australia, Canada, Switzerland and Singapore to help secure improved patient access to high-quality, safe and effective medicines.

Whilst a level of concern about Brexit still exists, bodies like the MHRA and its stakeholders appear to be considering the opportunities that it presents. It is also worth noting that COVID-19 has perhaps bolstered this ambition – particularly in relation to the need for regulatory flexibilities, faster clinical trial approvals and greater use of virtual meetings, telehealth and artificial intelligence.

Decideum has produced a MHRA-and-Project-Orbis-Briefing examining the future of the UK medicines and medical devices regulation landscape, including our analysis of the opportunities Project Orbis presents.

December update:

On 10 December, the MHRA issued guidance on Project Orbis, explaining the assessment process and eligibility criteria for treatments to be considered. Only new marketing authorisations applications (MAA) and new indication applications (variations) for oncology products are eligible to participate in the new scheme. In addition, drugs must be intended to treat a serious condition, and must show that, if approved, would provide significant improvements in either safety or effectiveness. The timing of the submission will determine the extent of collaboration between the FDA and participating partners, with applications submitted to all parties within 30 days for maximum collaboration.

For further questions please contact will.greenhill@decideum.com

By Will Greenhill

Consultant

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