Regulation& Development Investment
Why agility matters in innovation and regulation Dr Lorraine Nolan, Chief Executive, Health Products Regulatory Authority, examines the innovations that will drive the medical/biopharmachem sector, including advanced therapy medical products and the evolution of the connected health era, and explains how our healthcare regulator has to remain agile to ensure the system and approach to regulation meets current and future needs. BPCI’s BioPharma Ambition conferences, focusing on excellence in innovation and development in pharmaceutical, biopharmaceutical and chemical manufacture and supply, present a unique opportunity to showcase a sector in Ireland which continues to excel. These conferences continue to demonstrate not only an impressive evolution for BPCI but also for the sector as a whole. The messaging reflects BPCI’s and its member’s acute awareness that past performance does not guarantee future success without sustained future investment in development and manufacture of medicines in Ireland. The HPRA, as the regulator, values the focus BPCI places on continually monitoring and acting on the many aspects of the changing environment.
The importance of agility It is clear that it has never been more necessary for manufacturers to be agile and adaptable, ready to compete for investment in new and next generation manufacturing technologies. In parallel, for regulators, agility is essential to ensure the system and approach to regulation
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meets current and future needs. It could be said that it is an unsurmountable challenge to regulate a sector which is at the forefront of technological innovation, particularly with respect to the biopharmaceutical manufacturing sector, where facilities are state of the art and feature cutting edge technology. To me, this is not so much about the challenge but about the incredible opportunity it has afforded our organisation to contribute to patient health protection across the globe, where the medicines produced in Ireland are consumed globally, and provide critical, lifesaving and life altering treatment options to patients.
Achieving optimum regulation The HPRA has had to adapt and engage to ensure preparedness to achieve optimum regulation for the sector. This includes how we function and interact, our expertise requirements and ensuring that our regulatory and policy approaches remain fit for purpose in light of evolving needs. Part of our response includes working to enhance mechanisms for collaboration and harmonisation
with other regulators across the globe. Innovators set the direction and the pace for the evolution of regulatory processes. Innovators bring forward the scientific development in products, technology and processes. To regulate effectively, we require innovators, whether working in industry or non-commercial settings, to engage with us earlier and earlier in their development pipeline. The HPRA has always supported innovation but since the establishment of the HPRA’s Innovation Office in 2016, we have increased our outreach and offering. Much of this is built on engagement with our stakeholders at an early stage to sense and analyse needs. This is reinforced at European level through the EU innovation network, the European Medicines Agency’s (EMA) Innovation Task Force and indeed the EMA’s ‘Regulatory Science to 2025’ strategy, which plans to advance EMA’s engagement with regulatory science over the next five to 10 years. Inevitably, working on a network basis provides access to a wider pool of expertise. This offers huge future potential, particularly with the development of centres of excellence and pools Irish PharmaChem | Industry Buyers Guide 2020