Once the UK leaves the EU, the country will gain the autonomy for streamlining approval processes for medicines, joining other countries, such as the US, Canada, Australia, Switzerland, Singapore, and Brazil, in speeding up the approval of innovative medicines, including cancer treatments.
According to GOV.UK press release, the UK will join two initiatives that will bring together some of the world’s leading regulators to allow pharmaceutical companies to submit medicines and treatments to be reviewed by several countries simultaneously, pooling resources, which will allow patients to benefit from earlier access.
Health and Social Care Secretary Matt Hancock said: “I will stop at nothing to make sure NHS patients can access life-saving treatments as quickly as possible and now we have left the EU, we have an opportunity to speed up the time it takes to get new medicines from bench to bedside.”
He added that it had become clear with the UK’s work on dexamethasone and other COVID-19 treatments, that the country leads the way with research into transformative treatments. He said he was ‘delighted’ the UK will be collaborating with global regulators to put patients first by fast-tracking cutting edge medicines.
Both groups will aim to ensure that patient safety and scientific integrity is upheld to the highest possible standards while removing red tape and working together to get medicines onto the market quicker.
The two approval initiatives include:
Project Orbis is a programme coordinated by the US Food and Drug Administration (FDA) involving Canada, Australia, Switzerland, Singapore, and Brazil to review and approve promising cancer treatments.
The initiative has already given the green light to life-saving treatments for patients suffering from conditions such as breast cancer, lung cancer, liver cancer, endometrial cancer, and chronic lymphocytic leukaemia.
The Access consortium programme involves Australia, Canada, Switzerland, and Singapore in helping secure improved patient access to high-quality, safe, and effective medicines. The consortium has already approved nine innovative prescription medicines, including five new cancer treatments.
Both groups will be monitored by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and will become a full participant after the EU transition period on 1 January 2021.
The final decision to authorise medicines onto the UK market will be with MHRA, who will have complete autonomy to streamline the approval processes further if required.
Dr June Raine, MHRA Chief Executive, said: “We are committed to working together to ensure that UK patients are among the first to benefit from promising life-saving treatments. Through our commitment to international cooperation and innovation in regulation, the MHRA continues to be at the forefront of new developments as a global hub for life sciences.”
Richard Pazdur, MD, Director, FDA Oncology Center of Excellence, explained that Project Orbis was developed from a monthly teleconference between the FDA and other regulators, which indicated that the US typically receives applications months or even years before other countries.
“We decided to address this by partnering with other countries and asking the pharmaceutical companies to submit applications to several regulators at about the same time, to provide early entry of these applications into their regulatory systems,” he said.
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