A bold future for life sciences regulation has been saved
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.
Today, 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.
However, this latest predictions report from the Deloitte Centre for Health Solutions shows a bold future for regulation in the life sciences industry. One in which collaborative working between the regulator and industry, enabled by developing technologies, supports positive and innovative outcomes for patients.
Our four key predictions for life sciences regulation in 2025 are brought to life by imagining how regulators, industry and patients might behave in this new world. We purposefully present an optimistic view of the future, designed to enable industry leaders to grasp the disruption and transformation opportunities that lie ahead.
Four predictions for life sciences regulation in 2025
- Regulators will be globally aligned and coordinated – We have already seen streamlining of regulation between Canada and the US, as well as moves from bodies across South East Asia, Australia and APAC in harmonising regulation across their regions. By 2025, we foresee that regulation will be aligned at a national and international level, benefiting from a more collaborative approach using co-regulation and self-regulation, and regulators will have robust data sharing arrangements in place.
- Industry and regulatory bodies will collaborate effectively to mutual benefit – The industry and regulators will work closely and share ‘real-time’ data. The regulatory approach will become outcome based, data-driven and segmented, with automation becoming a game changer in enabling significant proportions of reporting to be automated. The FDA has already implemented a programme to assess the safety and effectiveness of software technologies without inhibiting patient access, and the EMA has introduced a portal that allows developers to consult with health technology assessment bodies and regulators simultaneously.
- New data-driven approaches will enable regulators to make faster approvals and balance risk – Data collected outside of clinical trials will lead to the creation of new evidence frameworks. Similarly, Blockchain technology could be harnessed to verify the origin of data submissions. The FDA has already supported innovation of this kind with its use of bio markers and its 2018 guidelines on modernising oncology trials.
- Productivity will be revolutionised by technology – Technologies such as AI, robotic process automation and natural language generation will become commonplace in clinical trials and streamline processes, allowing regulators to undertake faster review and feedback, and focus more on decisions and action where needed.
Bottom line: Ambitious but achievable
Achieving this more positive vision of the future and delivering better outcomes for patients will require regulators and the industry to:
- develop more efficient and effective systems and processes;
- acquire new skills and talent;
- and deploy new generation technologies more effectively.
Indeed, the skill set and engagement strategies of regulators will look quite different from today, and life science companies will need to re-programme their regulation mind-set to create a new, more collaborative environment that drives a culture change across the industry. This is a future in which patients are fully engaged in designing regulations, companies are truly patient-centric and the regulatory function of each life science company has moved from being a back-office enabler to a strategic business partner.
Preparing for the future
The new European Union medical devices regulation
EU Clinical Trial Regulation
Building a successful program