Recently, the National Medical Products Administration (NMPA) has issued the Rules for Applicable Discretion of Administrative Penalties in Drug Supervision and Administration (“the Rules”), which is intended to be implemented from August 1, 2024. The Rules for Applicable Discretion of Administrative Penalties for Drugs and Medical Devices (GSYJF [2012] No. 306) printed and issued in 2012 was simultaneously repealed.
The introduction of the Rules is an important move to thoroughly apply the Xi Jinping Thought on the Rule of Law, promote the modernization of drug safety governance system and capacity, comprehensively carry out the administrative discretion benchmark system for drugs, and standardize the discretion of administrative penalties for drugs. The Rules have been developed with in-depth investigations, extensive consultations and repetitive argumentations carried out and the actual needs of drug regulation and law enforcement taken into full account based on the careful collation of general requirements on discretion of administrative penalties, in a bid to exercise the discretion of administrative penalties in drug regulation in a more scientific, systematic and standardized manner.
The Rules include totally 54 articles under 6 chapters, which focus on improving the exercise of discretion of administrative penalties in drug regulation in four dimensions. First, the situation when the discretion is exercised is detailed. The Rules further define the situations when a severe or light penalty, or no penalty, or an exemption from penalties and aggravating circumstances should apply, clarify the specific meaning, identification situation and main judgment factors for the first and minor offenses as specified in the Administrative Punishment Law of the People's Republic of China in combination with the actual facts of drug regulation, and response to the great concerns from drug regulatory authorities at all levels, law enforcement officials at grass-roots level and enterprises. Second, the procedure for exercising the discretion is standardized. The Rules emphasize that the principles of evidence collection by law and in a comprehensive and objective manner should be followed in the exercise of discretion, that the statement and explanation made by the parties should be fully heard, and the proceedings should be performed according to law, such as hearing, group discussion and justification for discretion. Third, the principles for establishing the discretion benchmarks are specified. The Rules further improve the procedures and rules for establishing administrative discretion benchmarks for drugs in all regions, regulate the principles, requirements and procedures for establishing the discretion benchmarks, and provide more details on the determination of the amount of fines, the scope of “penalty to specific persons” and the calculation of illegal gains. Fourth, the supervision over the exercise of discretion is strengthened. The Rules require that drug supervision and administration departments at all levels should execute the law enforcement responsibility system and the fault accountability system, that the mechanism for supervising the discretion of administrative penalties should be established and improved, and that the typical case-based guidance should be promoted, to rectify any violation of law, or obvious improper administrative discretion bench or behavior in time, and continuously standardize the exercise of discretion of administrative penalties.
The formulation and issuance of the Rules are very helpful for accurately applying the Administrative Punishment Law of the People's Republic of China and the “Two Laws and Two Regulations” on drug regulation (i.e., the Vaccine Administration Law of the People’s Republic of China, the Drug Administration Law of the People’s Republic of China, the Regulations on the Supervision and Administration of Cosmetics, and the Regulations on the Supervision and Administration of Medical Devices) in the drug regulation and administration departments, guiding the law enforcement officials at grass-roots level to enforce laws in a strict, standardized, impartial and civilized manner, promoting the standardized, normalized and scientific law enforcement in drug regulation across the country, and creating a fair and just regulatory environment for enterprises. The NMPA will organize a series of publicity and training activities on the Rules in the near future, carry out policy interpretation for the administrative law enforcement officials across the system, and guide the earnest implementation of the Rules in all regions, in order to ensure the policy implementation, practically standardize the actions to impose administrative penalties in drug regulation, and protect the legal rights and interests of citizens, legal persons and other organizations.
Source: National Medical Products Administration
The introduction of the Rules is an important move to thoroughly apply the Xi Jinping Thought on the Rule of Law, promote the modernization of drug safety governance system and capacity, comprehensively carry out the administrative discretion benchmark system for drugs, and standardize the discretion of administrative penalties for drugs. The Rules have been developed with in-depth investigations, extensive consultations and repetitive argumentations carried out and the actual needs of drug regulation and law enforcement taken into full account based on the careful collation of general requirements on discretion of administrative penalties, in a bid to exercise the discretion of administrative penalties in drug regulation in a more scientific, systematic and standardized manner.
The Rules include totally 54 articles under 6 chapters, which focus on improving the exercise of discretion of administrative penalties in drug regulation in four dimensions. First, the situation when the discretion is exercised is detailed. The Rules further define the situations when a severe or light penalty, or no penalty, or an exemption from penalties and aggravating circumstances should apply, clarify the specific meaning, identification situation and main judgment factors for the first and minor offenses as specified in the Administrative Punishment Law of the People's Republic of China in combination with the actual facts of drug regulation, and response to the great concerns from drug regulatory authorities at all levels, law enforcement officials at grass-roots level and enterprises. Second, the procedure for exercising the discretion is standardized. The Rules emphasize that the principles of evidence collection by law and in a comprehensive and objective manner should be followed in the exercise of discretion, that the statement and explanation made by the parties should be fully heard, and the proceedings should be performed according to law, such as hearing, group discussion and justification for discretion. Third, the principles for establishing the discretion benchmarks are specified. The Rules further improve the procedures and rules for establishing administrative discretion benchmarks for drugs in all regions, regulate the principles, requirements and procedures for establishing the discretion benchmarks, and provide more details on the determination of the amount of fines, the scope of “penalty to specific persons” and the calculation of illegal gains. Fourth, the supervision over the exercise of discretion is strengthened. The Rules require that drug supervision and administration departments at all levels should execute the law enforcement responsibility system and the fault accountability system, that the mechanism for supervising the discretion of administrative penalties should be established and improved, and that the typical case-based guidance should be promoted, to rectify any violation of law, or obvious improper administrative discretion bench or behavior in time, and continuously standardize the exercise of discretion of administrative penalties.
The formulation and issuance of the Rules are very helpful for accurately applying the Administrative Punishment Law of the People's Republic of China and the “Two Laws and Two Regulations” on drug regulation (i.e., the Vaccine Administration Law of the People’s Republic of China, the Drug Administration Law of the People’s Republic of China, the Regulations on the Supervision and Administration of Cosmetics, and the Regulations on the Supervision and Administration of Medical Devices) in the drug regulation and administration departments, guiding the law enforcement officials at grass-roots level to enforce laws in a strict, standardized, impartial and civilized manner, promoting the standardized, normalized and scientific law enforcement in drug regulation across the country, and creating a fair and just regulatory environment for enterprises. The NMPA will organize a series of publicity and training activities on the Rules in the near future, carry out policy interpretation for the administrative law enforcement officials across the system, and guide the earnest implementation of the Rules in all regions, in order to ensure the policy implementation, practically standardize the actions to impose administrative penalties in drug regulation, and protect the legal rights and interests of citizens, legal persons and other organizations.
Source: National Medical Products Administration