The effectiveness of the EU's medicines regulations has never before been so scrutinised. Earlier this year the event of Brexit necessitated reflection on the European system. More recently, whilst the COVID-19 global pandemic has served to galvanise the industry's fundamental importance to society as a whole, it has also placed its regulatory regime under a microscope and reignited the age old debate of whether the regime, alongside all other EU product safety regimes, is suitable for modern world issues such as COVID-19 and fast-paced technological innovation.
Building on two previous iterations of the document produced since 2000, the European Medicines Agency (EMA), EU Medicines Regulatory Network (EU network/EMRN), and the European Commission (the Commission) have recently announced their 5-year strategy: Regulatory Science Strategy to 2025.
The report, as the name suggests, focuses on the relationship between science and regulation that is fundamental to this area and strengthening the discipline of regulatory science, defined in the report as "the range of scientific disciplines that are applied to the quality, safety and efficacy assessment of medicinal products and that inform regulatory decision-making throughout the lifecycle of a medicine. It encompasses basic and applied biomedical and social sciences and contributes to the development of regulatory standards and tools".
The report tackles big themes that resonate with general international product safety topic issues, including: personalisation of medicines; use of novel technologies (AI/digital technology) in both manufacture and decision-making, more sophisticated use of data (big data and AI); international collaboration and information-sharing and modernisation of consumer-facing materials.
In keeping with the above, five key strategic goals and core recommendations, with specific underlying initiatives, have been identified to achieve the overarching goal for human medicines specifically: "to underpin its mission of protecting human health, EMA must catalyse and enable regulatory science and innovation to be translated into patient access to medicines in evolving healthcare systems."
- Catalysing the integration of science and technology in medicines development by focusing on precision medicines, special population initiatives, modelling, simulation and extrapolation capabilities and use of digital technology and artificial intelligence in EMA regulatory decision-making.
- Advancing patient-centred access to medicines in partnership with healthcare systems by focusing on innovative medicines, collaboration between all actors within the healthcare system, patient factors and their impact on evidence generation, high-quality real-world data (RMD), big data, product information in electronic format (ePI), biosimilars and EMA external engagement and communications to be more transparent.
- Addressing emerging health threats and availability/therapeutic challenges by focusing on EMA's programme for health threat preparedness, creation of new antibacterial agents and alternatives, global supply chain initiatives, innovative approaches to vaccine regulatory pathways and repurposes existing medicine authorisations for other uses.
- Enabling and leveraging research and innovation in regulatory science by working with expert regulatory science institutes, collaborating with academia and network scientists to determine research frameworks and expert information exchange.
Although the implementation of the EMA's 5 year strategy remains to be seen, some of its resolutions have already been put to the test in the COVID-19 crisis. For example, as part of efforts under strategic goal 4 above, the EMA founded a COVID-19 pandemic Task Force (COVID-ETF) to help Member States and the European Commission take quick and coordinated regulatory action on the development, authorisation and safe monitoring of treatments and vaccines intended for the treatments and prevention of COVID-19. More information of the EMA's governance during the pandemic and their business continuity plan can be found here.
In the interim, with knowledge that the EMA, ERMN and the European Commission, will shortly commence its consultation and drafting process again for its next 5-year plan, those in the medicines industry are encouraged to keep detailed, thorough analysis and feedback on the effectiveness of regulation for their purposes, including in particular novel medicines and new technologies, in anticipation of participation in the next public consultation.
Originally published by Cooley, September 2020
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