On May 2, 2024, the  American Journal of Pharmaceutical Innovation published a paper by Dr. Zheng Qiang's research team from Peking University's College of Engineering and the Institute for Global Health and Development. The paper, titled "A Dynamic Model for GMP Compliance and Regulatory Science," is the world's first article to treat regulatory science as a scientific discipline.

China has already established over a hundred research centers for regulatory science. The concept of regulatory science was proposed by Alan Moghissi, who worked for the US Environmental Protection Agency in the 1980s and founded the Institute for Regulatory Science. Professor Sheila Jasanoff from Harvard University's Kennedy School of Government has also been engaged in regulatory science research for a long time. However, despite many discussions about regulatory science, a scientific definition has yet to be seen.

The US FDA describes regulatory science as the science of developing new tools, standards, and methods to assess the safety, effectiveness, and performance of products. The goal of researching regulatory science is to make regulations more effective. However, not all scientific methods that improve regulatory effectiveness belong to regulatory science. So far, most methods reported in the literature are applications of medicine, pharmacy, statistics, life sciences, chemistry, manufacturing science, and decision science in regulation.

Perhaps regulatory science is not an independent discipline or field that requires its own basic concepts, principles, and methods. Without regulatory science, wouldn't the pharmaceutical industry and drug regulation still develop? Innovation continues, and human health still advances. However, if we must delve into the essence of regulatory science, the issues mentioned above are unavoidable.

Science aims to explore the essence of things. From an application perspective, the benefit (not the goal) of exploring essence is that it can solve a large class of problems at once, not just individual issues. Without deep foundations, applications lack systematicity and sustainability.

This article uses pharmaceutical GMP compliance regulation as an example to explore the fundamentals of regulatory science. The foundation questions the article explores are: What are the basic principles, measures, and quantitative relationships in regulatory science? The practical regulatory questions the article aims to answer are: What is the overall compliance status of the pharmaceutical industry? Is it improving, stable, or deteriorating? How can it be improved?

Disciplinary Foundation:

The article proposes three basic principles—proportionality, transparency, and consistency—and three basic measures of regulatory effectiveness—efficiency, cost, and quality. It introduces a generalized Ornstein-Uhlenbeck dynamic stochastic differential equation to describe the relationships between basic principles and measures. The conclusion is that the relationships between the principles of proportionality, transparency, and consistency and the measures of efficiency, cost, and quality can be systematically and quantitatively described by the aforementioned equation.

Compliance Regulation:

The article also provides answers to questions such as "What is the overall compliance status of the pharmaceutical industry? Is it improving, stable, or deteriorating? How can it be improved?" Increasing transparency can significantly improve regulatory effectiveness. Inconsistent enforcement does not greatly affect the industry's average compliance status but significantly affects variance, leading to polarization in compliance status. Given fixed regulatory costs, transparency, and consistency, increasing regulatory frequency is more effective than increasing the number of concurrent inspections. For example, if the total number of GMP inspections is fixed (100 times), inspecting 50 companies twice (50x2="100)" is less effective than inspecting 20 companies five times (20x5="100).

The article's primary intention is not to solve practical regulatory issues but to explore the foundational theoretical issues of regulatory science. However, clarifying these foundational issues has unexpectedly solved previously practical problems. Those interested in the article are welcome to click "Read the original text" and visit GHD’s website at Peking University to view the English original and Chinese translation.

(Interpreted by Waverly Shi)