A bold future for life sciences regulation
A special look at how life sciences regulation is evolving to support positive and innovative outcomes for patients.
Currently, there is an increasingly complex and fragmented life sciences regulatory landscape, which is struggling to keep pace with the exponential changes in medicine, science and technology while protecting patient safety.
Drawing on our combined expertise in working with regulators and the regulatory industry, we have developed four bold and optimistic predictions of what regulation in the life sciences industry might look like in 2025.
Four predictions for life sciences regulation in 2025
- Regulators will be globally aligned and coordinated – Regulation has been aligned at both a national and international level, with regulators around the world benefiting from more collaborative approaches such as co-regulation, self-regulation, and international co-ordination. This approach has encouraged innovation while protecting consumers from potential fraud or safety.
- Regulatory relationships are based on a “win-win” data driven approach. – Regulators, patients and industry (including non-traditional health care players) work closely together, sharing “real-time” data to enable faster review and feedback. Regulators have created a digital platform for more “self-regulation” moving management of risk closer to those affected by it. Regulation is outcome-based, data driven and segmented, using advanced analytics to detect new patterns and trends, to ensure that products are safe, effective and personalised.
- Regulators successfully balance rapid innovation with real-time regulation – New data-driven approaches enable faster regulatory approvals, better sharing of risk and value to patients. Regulators now expect real-world evidence (RWE) to support decisions for approving new drug applications (NDAs), label extensions and revisions. The increasing reliance on data collected outside the controlled environment of clinical trials has led to the creation of new evidence frameworks and the development of new skillsets and capabilities within regulatory bodies.
- A technology-enabled approach is driving the productivity and quality of regulation – Advanced technologies and robotics have improved the efficiency and speed of regulatory activity. Regulators and industry have both adopted next generation (“4th industrial revolution”) technologies to automate processes and help improve the speed and quality of regulatory oversight. Technology is enabling regulators to process the large amounts of data available to them to make faster, better decisions and take regulatory action where there is a perceived issue with product safety.
Bottom line: Ambitious but achievable
Although we recognise that our four predictions are an optimistic view of what the life sciences regulatory landscape might look like in 2025, we contend that the vision it presents is achievable. However, this will require regulators and industry to embrace the following three enablers:
- wide-scale adoption of new digital and cognitive technologies
- recruitment and retention of new skills and talent
- streamlined and agile systems and processes
These enablers are critical for realising each of our predictions, and the speed of adoption will inevitably impact the speed of change.
In conclusion, our four predictions draw on insight provided by our Global Centre of Regulatory Excellence.
In the Irish marketplace today, especially with the uncertainties emerging from the progression of Brexit, life science leaders who binging attention and focus to the four areas mentioned above will be better prepared to drive efficiencies and quality and improve the reputation of the industry with all stakeholders.