According to the website of the National Medical Products Administration, the Administration recently released the "Rules for the Application of Administrative Penalty Discretions in Drug Supervision and Administration" (National Medical Products Administration Law [2024] No. 11), which will come into effect on August 1, 2024. The Administrative Penalty Discretionary Application Rules for Drugs and Medical Devices (State Food and Drug Administration Law [2012] No. 306) issued in 2012 are simultaneously abolished. The Rules for the Application of Administrative Penalty Discretion in Drug Supervision and Administration consist of six chapters and fifty-four articles, with a focus on improving the work of administrative penalty discretion in drug supervision and administration in four aspects. One is to improve the discretion situation. Further refinement has been made on the severity, leniency, refusal, exemption from punishment, and serious circumstances. In response to the initial violation and minor consequences stipulated in the Administrative Penalty Law, combined with the actual situation of drug supervision, specific meanings, determination situations, and main factors for determination have been clarified. This has responded to the high attention of various levels of drug regulatory departments, grassroots law enforcement personnel, and enterprises. The second is to standardize the discretion procedure. We have strengthened the principle of lawful, comprehensive, and objective evidence collection in our discretion. We should fully listen to the statements and defenses of the parties involved, and emphasize the procedures of holding hearings in accordance with the law, conducting collective discussions, and explaining the reasons for our discretion. The third is to clarify the principles for setting discretionary benchmarks. We have further improved the procedures and rules for establishing discretionary standards for drug penalties in various regions, standardized the principles, requirements, and procedures for establishing such standards, enriched the determination of fine amounts, the scope of penalties imposed on individuals, and the calculation of illegal gains. The fourth is to strengthen discretionary supervision. Require drug regulatory departments at all levels to implement the law enforcement responsibility system and the fault accountability system, establish and improve the supervision mechanism for administrative penalty discretion, promote guidance on typical cases, timely correct illegal or obviously inappropriate administrative penalty discretion standards or behaviors, and continuously standardize the exercise of administrative penalty discretion. The formulation and publication of the "Administrative Penalty Discretionary Application Rules for Drug Supervision and Administration" accurately apply the "Administrative Penalty Law" and the "Two Laws and Two Regulations" for drug supervision departments, guide grassroots law enforcement personnel to strictly regulate, fair and civilized law enforcement, promote the standardization, normalization, and scientificization of drug supervision and law enforcement nationwide, and create a fair and just regulatory environment for enterprises, which is of great significance. (Lai Xin She)
Edit：GuoGuo Responsible editor：FangZhiYou
Source：people.cn
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