[Legal Update] NMPA Clarifies Drug Supervision Rules
2024. 3. 29
[Legal Update] NMPA Clarifies Drug Supervision Rules
The National Medical Products Administration (‘NMPA’) has clarified the rules for applying discretion in the administrative punishment of drug supervision and management. Recently, the NMPA announced the "Rules for Applying Discretion to Administrative Punishments in Drug Supervision and Management" (hereinafter referred to as "Discretion Rules"), which will be implemented from August 1, 2024.
The Discretion Rules mainly clarified the following points:
1. Improved the discretionary situation. Detailed heavy punishments, light punishments, non-punishments, punishment exemptions, and malicious circumstances, and stipulated specific definitions, circumstances to be recognized, and main elements of judgment for the first violation and minor harm results stipulated in the "Administrative Penalty Law", taking into account the actual situation of drug supervision and management.
2. Strengthened the principle of discretion by law and comprehensive and objective evidence collection, fully listened to the statements and defenses of the parties, strongly advocated the process of holding public hearings by law, conducting group discussions, explaining discretionary reasons, etc.
3. Improved the process and rules for formulating the standards of drug punishment discretion in various places, stipulated the principles and requirements for formulating discretionary standards and processes, and enriched the determination of fine amounts, the scope of punishment targets, and the calculation of illegal income, etc.
4. Required all levels of National Medical Products Administration to implement the responsibility system for law enforcement and the system for pursuing negligence liability, establish a supervision system for the discretionary standards of administrative punishments, promote the guidance of typical cases, correct the standards and behaviors of illegal or obviously unfair administrative punishments in a timely manner, and require the normative exercise of administrative punishment discretionary power.
