The regulation of healthcare products (medicines, medical devices and diagnostics) has evolved over the past 50 years from a system focused on the review and control of the safety, quality and efficacy of products, evaluated by national regulators; to a prospective science-driven and globally collaborative system. This evolution might be described in three stages: development of regulatory systems, largely based on past experience; international collaboration and developing common standards; and most recently the emergence of regulatory science and regulators supporting innovation.
As we look forward to 2020 and beyond, the rapidly increasing understanding of molecular biology and the genetics of disease leads to personalisation of therapeutics with an integration of medicines and diagnostics. This complex biology and novel therapeutics will present regulators, developers and society with unprecedented challenges in the regulation of healthcare products. The integration of healthcare data and social networking provides huge opportunities in the real world understanding of both common and rare diseases.
The evaluation of post-market safety data is well established; but, the application of real-world evidence to understanding both benefits and risks should facilitate the development of optimised use of both existing and new therapies. Involvement of patients in the development of medicines and regulatory decision-making will reform our approach to medicines regulation. Increased transparency and the availability of data and sophisticated analytical tools will require increased global collaboration between regulators.
While the trends highlighted here are well known, it is likely that we will see unexpected challenges to our regulatory environment and the regulatory professional will need to keep pace with scientific development, societal expectations, communications and leadership skills required to contribute in a rapidly changing environment.