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RAPS Statement - BREXIT delay
Regulatory Affairs Professionals Society's Executive Director, Paul Brooks, discusses the looming uncertainty about what will happen after the UK leaves the European Union as many important details remain unclear.
Now that Prime Minister Theresa May’s request for a Brexit deadline extension has been granted, it will provide time to make needed preparations. Uncertainty about what will happen after the UK leaves the European Union has been a major concern for regulatory affairs professionals working in pharmaceutical and medical device companies since the day the result of the Brexit referendum was announced in 2016. Regulatory professionals
Paul Brooks
provide strategies and guidance to ensure needed healthcare products continue to flow into healthcare systems and are available to patients across Europe. Clarity on how the post-Brexit EU regulatory system and a newly separate UK system will operate relative to one another is urgently needed. Regulatory strategies responding to any change take significant time and resources to implement and need to continuously address clear regulator expectations.
Unfortunately, now more than two years later, many important details remain unclear. Taking additional time to hammer out important points and possibly get a deal in place could only help, but it will be critical to use the extra time productively. In the end, if UK and EU regulations, processes and procedures diverge significantly, or if the two sides fail to agree on some form of mutual recognition, it could lead to duplication of regulatory efforts, most likely resulting in increased costs, time and resourcing for manufacturers, and possibly threatening the availability of current life-saving medicines and medical technology for healthcare providers and patients, as well slowing down access to enhanced or innovative solutions.
The post-Brexit regulatory environment continues to weigh heavily on the minds of regulatory professionals who must guide and advise companies wishing to preserve access to such products. It is one of the major topics we will be examining at the upcoming RAPS Regulatory Conference – Europe 2019, this May in Brussels with separate sessions regarding pharmaceuticals and devices in the post-Brexit era.
Johnson & Johnson Seeks FDA Approval for Subcutaneous Tremfya Regimen for Ulcerative Colitis
November 22nd 2024Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis based on positive Phase III ASTRO trial results.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
