Recently, the Rules for the Application of Discretion in Imposing Administrative Penalties in the Supervision and Administration of Medicinal Products (hereinafter referred to as "Rules") were issued by China NMPA, which will come into force from August 1, 2024 onwards. The Rules for the Application of Discretion in Imposing Administrative Penalties in the Supervision and Administration of Medicinal Products and Medical Devices (SFDA [2012] No. 306) issued in 2012 are abolished at the same time.

The introduction of the Rules represents a significant step in implementing Xi Jinping's thought on the rule of law and modernizing the drug safety governance system and governance capacity. It also aims to fully implement the benchmark system of drug administrative discretion, and standardize the discretionary power of drug administrative penalties. In the process of formulating the Rules, the NPMA conducted exhaustive investigations, consultations, and demonstrations to strike an optimal balance between the general requirements for discretionary administrative penalties and the concrete demands of drug supervision and law enforcement. By seamlessly integrating these elements, the NPMA creates a framework that supports the scientific, systematic, and standardized application of the discretionary administrative penalties for drug supervision.

The Rules consist of six chapters and 54 articles, focusing on four aspects to improve the discretionary administrative penalties for drug supervision. Firstly, the discretionary circumstances have been improved. The criteria for aggravating, mitigating, withholding, exempting from punishment, and aggravating circumstances have been further refined. Additionally, in the context of drug supervision for first-time offenders and minor harm consequences, as specified in the Law of the People's Republic of China on Administrative Penalty, the specific meaning, determinants, and main factors for judgment have been clarified, responding to the high level of concern of various parties, including the drug regulatory departments at all levels, grass-roots law enforcement personnel, and enterprises. Secondly, the discretionary procedure has been standardized. The emphasis has been placed on ensuring that the discretionary procedure adheres to the principles of legal, comprehensive, and objective evidence collection, and the statements and pleadings of the parties should be fully heard, emphasizing the procedures of public hearing, collective discussions, and justification of discretion in accordance with the law. Thirdly, the principles for the formulation of the discretionary benchmarks have been clarified. The procedures and rules for formulating the discretionary benchmarks for drug penalties all over China have been further improved. The principles, requirements, and procedures for formulating the discretionary benchmarks have been standardized, ensuring that the criteria for determining fines, scope of penalties for individuals, and calculations of illicit profits are clearer and more comprehensive. Fourthly, discretionary oversight has been strengthened. Drug regulatory departments at all levels are required to implement a law enforcement accountability system and a fault accountability system, and establish and improve discretionary supervision mechanisms for administrative penalty. They must also promote typical case guidance, promptly address any illegal or blatantly improper administrative penalty discretionary benchmarks or behaviors, and continually standardize the exercise of administrative penalty discretion.

The formulation and issuance of the Rules are of great significance to the drug regulatory departments, as they facilitate the precise implementation of the Law of the People's Republic of China on Administrative Penalty and the two laws (Drug Administration Law of the People's Republic of China and Vaccine Administration Law of the People's Republic of China) and two regulations (Regulations for the Supervision and Administration of Medical Devices and Regulations on Supervision and Administration of Cosmetics) on drug supervision, and guides grass-roots law enforcement personnel to carry out their duties in a strict, fair, and civilized manner, contributing to the standardized, normalized, and scientific law enforcement in drug supervision all over China. This, in turn, creates a fair and just regulatory environment for enterprises. In the near future, China NMPA will organize and implement a series of educational and training programs on Rules to provide administrative law enforcement personnel across the country with a deeper understanding of the policy and its implementation. This initiative aims to ensure that all localities conform to the policy and enforce it effectively, thereby standardizing administrative penalties for drug-related infractions and safeguarding the legitimate rights and interests of citizens, legal entities, and other organizations.