What’s trending in regulatory affairs? PharmaMedic in discussion with Dr Zubair Hussain 7 Jun 2022
At PharmaMedic, we support pharmaceutical, biotech, and medical devices organisations with a suite of regulatory and medical affairs services, from support with marketing authorisations to strategic and technical advice on development programmes.
Last year, our colleague Dr Zubair Hussain, Chairman of LE4D Global Regulatory and a PharmaMedic partner, provided an insightful strategic update on critical regulatory trends at PharmaMedic’s inaugural virtual breakfast briefing. At the time, Zubair highlighted regulatory interest in complex clinical trial designs and their potential role in furthering innovation, how Brexit would impact the function of the MHRA, and the implication of regulation changes for medical devices.
We felt it was time we sat down again with Zubair to get his updated insights on what three issues he tips for the top of the regulatory agenda over the coming months. Below is a summary of the perspectives he generously shared with us:
Notified bodies for medical devices
As those working in the medical devices field know, notified bodies play an essential role in ensuring safety and compliance. Since the Medical Devices Directive was repealed and replaced by the EU Medical Device Regulation (MDR), the standard that notified bodies had to meet was raised, substantially reducing their number. This reduction, combined with the disruption of the pandemic, has meant there is now a significant backlog for medical device manufacturers obtaining the required certification to keep their products on the market. Notably, this issue doesn’t only affect medical device businesses; it impacts pharmaceutical companies hoping to approve combination products that contain a medical device. Before filing a regulatory submission of a MAA in EU with the regulatory authorities, you must of course have the Notified Body Opinion on meeting the general safety and performance requirements of the MDR for the medical device component of the combination. Planning is, of course, always crucial in regulatory affairs–but now, more than ever, companies should put their best foot forward in handling the aspects of their regulatory file that would require notified body input.
UK clinical trials landscape
The government has been keen to make the UK an attractive destination for clinical trials and research after our exit from the EU and has often reiterated its ambition to make the nation a ‘life sciences superpower’.  But how much is that desire becoming a reality? An intriguing perspective came from an article for PharmaTimes, in February 2022. Angela McFarlane of IQVIA shared the results of primary research about the attractiveness of the UK with over 100 global life sciences executives and noted a ‘volte face’ in opinion between the results of 2018 and 2021. While in 2018, nearly 40% of the research respondents said the UK was a less attractive destination to conduct clinical trials, by contrast, in 2021, 76% of the respondents reported that the UK was considered the same or an even more attractive, clinical research destination since it had left the European Union. Interestingly, the study also reported a vote of confidence in the MHRA as a regulator. The recent introduction in January 2022 of Combined Ways of Working (CWOW) process aims to reduce clinical trial approval timelines making UK a more attractive country to initiate clinical trials. This new process promotes increased collaboration between the MHRA and HRA, there is a co-assessment of the clinical trial application resulting in a single UK decision. The aim of the initiative is to also ensure a more balanced and risk-based regulation of each clinical trial. At the same time, in considering recent innovation-supporting initiatives such as ILAP and Project Orbis, 88% of respondents indicated that their employer’s UK-based research and medicines launches would either increase or remain the same over the next four years. From these results, the government’s focus on life sciences may be showing signs of paying off. Still, we would be very interested to hear experiences from colleagues who have experience on the ground. Do let us know your thoughts and experiences at firstname.lastname@example.org.
In a reimagined regulatory environment, with the UK having separated from Europe, new connections between agencies are coming to the fore. After all, collaboration has been one positive feature arising from the pandemic. It’s no surprise then, that the MHRA’s delivery plan for 2021- 2023 highlights the importance of international partnerships and their goal of “Collaborating with other country regulators to provide quicker access to the next generation of cutting-edge treatments, while maintaining the highest safety standards by Q4, 2022/2023.”
In creating a regulatory plan, it’s important to consider the map of agency relationships and create a filing strategy that considers which countries will accept one another’s standards.
As an African proverb points out, “If you want to go fast go alone, if you want to go far go together.”
Thank you to Dr Zubair Hussain for his insights.
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About Dr Zubair Hussain
Dr Zubair Hussain has over 25 years of experience in Regulatory Affairs, Quality Assurance and Compliance. His experience includes senior positions in small and large pharmaceutical and medical device companies, with global responsibilities for the EU, US, China, Russia, Asia, and Latin America. His most recent corporate role was at Ipsen Biopharma where Zubair held a global position as Senior Vice President, Global Head of Regulatory Affairs.
Zubair has also previously held the position of President for the TOPRA board, the trade association for professionals in regulatory affairs. Since 2016, Zubair has been chairman of LE4D Global Regulatory Science, providing innovative regulatory and clinical strategies to the healthcare industry. For further information – https://www.le4d.co.uk/