The National Medical Products Administration (NMPA) has issued the “Rules for the Application of Administrative Penalty Discretions in Drug Supervision and Administration,” which will come into effect on August 1, 2024. These Rules, comprising 6 chapters and 54 articles, represent an enhancement of the 2012 version, with improvements in four key areas.
Firstly, the discretionary situations have been refined to better define severity, leniency, refusal, exemption from punishment, and serious circumstances. Clarifications have been made regarding the specific meaning, determination situations, and main factors for first-time violations with minor consequences under the Administrative Penalty Law, in the context of drug supervision realities.
Secondly, the discretionary procedure has been standardized, emphasizing the principles of lawful, comprehensive, and objective evidence collection. The statements and defenses of the parties involved are to be fully considered, with an emphasis on legal procedures for hearings, collective discussions, and explaining the reasons for discretion.
Thirdly, the principles for setting discretionary standards have been clarified, improving the procedures and rules for setting discretionary standards for drug penalties across various regions. This includes standardizing the principles, requirements, and procedures for setting discretionary standards, as well as enriching the determination of fine amounts, the scope of punishment for individuals, and the calculation of illegal gains.
Lastly, discretionary supervision has been strengthened, requiring drug regulatory departments at all levels to implement law enforcement responsibility systems and fault responsibility accountability systems. They are to establish and improve administrative penalty discretionary supervision mechanisms, promote typical case guidance, correct illegal or obviously inappropriate administrative penalty discretionary benchmarks or behaviors in a timely manner, and continuously standardize the exercise of administrative penalty discretionary power.- Flcube.com
