he Chinese pharmaceutical industry, through the first five years of China’s National Medical Products Administration (NMPA) regulatory reform which began in 2015, has experienced groundbreaking changes and stepped into a new era full of blooming innovation and intense competition. Today, the regulatory professionals are facing unprecedented opportunities as well as challenges in this diversified environment.

Global Forum spoke with Irene Deng, Sanofi’s China Regulatory Head and a member of the DIA China Advisory Council, about the evolution of the Chinese regulations, the impact of this evolution on the requirements for the regulatory profession, and some regulatory “Do’s and Don’ts” under today’s dynamic circumstances.

Global Forum: The highly anticipated Drug Registration Regulation promulgated in 2020 provides a landmark moment by introducing a new stage for China’s regulatory administration. How do you view the changes of China’s drug regulations in the past five years?

Irene Deng: Taking a holistic view of the evolution of Chinese regulations, we can see a trajectory from a progressive movement to a rapid advance, with persistent endeavors from the health authority (NMPA) supported by industry standing close behind.

• Before 2015, the agency had unremittingly explored stepping forward in regulatory science for many years. Industry efforts in partnership with the health authority helped to further shape regulation and harmonize guidance. All these efforts established the scientific base for the reform.
• Since the landmark No.44 Opinion from State Council opened China’s regulatory reform in 2015, changes in regulations started a quick evolution and achieved a watershed moment by the implementation of the updated Drug Administration Law and Drug Registration Regulation in 2019 and 2020, respectively. Over the last five years, rapid iterations and substantial changes have taken place in China’s regulatory landscape.

The extent and speed of China regulatory reforms seem much deeper and quicker compared to similar changes in the US with the FDA or in the EU with the EMA, like directly striding from the Cambrian to the Cenozoic era. As a result, these reforms pose certain newer and higher requirements to the regulatory work in China.

GF: Could you elaborate on some of these newer and higher requirements that the regulatory profession is facing in China?

ID: Let’s look at it from three main perspectives.

1. We must find ways to increase and improve regulatory comprehension and interpretation by:
• clearly seeing through the regulation structure and its relationship with other regulations to understand not just the wording or articles, but to (more crucially) understand the implication of the regulation;
• being agile enough to broaden the scope and deepen our scientific knowledge as new technologies constantly emerge; and
• taking a broader perspective that understands industry progress and its direction, and is conscious of developments in society.

For example: There are linkages between the Drug Registration, Drug Manufacturing Administration, and Drug Supply Administration regulations that reflect NMPA’s approach towards the entire lifecycle management. Regulatory professionals should take a comprehensive view to all relevant regulations and guidances and pay attention to the embedded logic, to thoroughly understand and grasp the essence of the regulations and apply it in their daily work.

2. This rapidly iteractive environment boosts higher demand for influential communication.
• Regulatory professionals can go further than bridging communication and understanding with industry and regulators to influence the future and propel regulatory progress by adapting to emerging technologies.
• In addition, cross-functional and cross-cultural communication has become increasingly important in light of global simultaneous drug development and the surging number of cross-border licensing deals.
• Regulators must also be able to adapt to VUCA (volatility, uncertainty, complexity, ambiguity) in this era and pinpoint the right directions for seeking win-win solutions for all.
3. It will be essential to construct strategies and have the power to execute and implement them. Applying regulatory interpretation into regulatory practice requires a thought-out strategy and implementation plan, and the capability to consistently execute the practice.

GF: Risk-based inspection is a highlight of the new regulation. How shall regulatory professionals support these inspections?

ID: Regulatory inspection requires cross-functional joint effort, with the regulatory function playing an essential role among them:

1. Clearly convey regulatory requirements such as procedures, risk assessment, etc., so the company can make their own comprehensive internal plan, and include an accurate timeline for project coordination and management.
2. Harness the strength of logic and communication to assemble and distribute all relevant information in a clear and structured way.
3. Closely collaborate with both internal and external stakeholders throughout the entire inspection process in search of perfect execution.

For example, assessing inspection results requires not only the function of quality compliance but also understanding the underlying scientific rationale and exercising logical judgement. The regulatory function should partner with all other relevant functions to clearly and logically present the totality of evidence to help the team arrive at an objective conclusion.

Regulatory affairs is a practical science. Regulatory professionals should not only rely on their past experience and simply repeat what they have already done. Rather, they should continue to accumulate experiences and hone their skills with self-reflection and insight, to realize the transformation from information to intelligence and from intelligence to insight.