Rules on Discretionary Application of Administrative Penalties in Drug Supervision and Administration Released
ISSUING AUTHORITY:
National Medical Products Administration
DATE OF ISSUANCE:
February 23, 2024
EFFECTIVE DATE:
August 1, 2024
On February 23, 2024, the National Medical Products Administration released the Rules on the Discretionary Application of Administrative Penalties in Drug Supervision and Administration (the “Rules”), with an effective date of August 1, 2024.
The Rules provided more detailed guidelines on the circumstances under which heavier, lighter, or no penalty may be applied for illegal activities within the field of drug supervision. For instance, the Rules improved and expanded the circumstances for imposing heavier administrative penalties mainly in the following three aspects: (i) it added the circumstances under which pharmaceutical precursor chemicals that pass off as other drugs should be severely punished; (ii) it added heavier penalties related to medical devices; and (iii) it introduced microbial limits as one of the criteria for assessing whether the drug is in compliance and exceeding microbial limits shall serve as a basis for heavier penalties.
Additionally, the Rules refined and clarified the fine ranges for general, reduced, lighter and heavier penalties by specifying the corresponding ratios. For instance, where the fine is a range of amounts, the reduced penalty should be less than the minimum fine amount, the lighter penalty should be less than 30% of the range between the minimum fine amount and the maximum fine amount, the general penalty should be between 30% and 70% of the range between the minimum fine amount and the maximum fine amount, and the heavier penalty should be more than 70% of the range between the minimum fine amount and the maximum fine amount.
Finally, the Rules also stipulate the authority of administrative departments at all levels to establish discretion standards for administrative penalties within the field of drug supervision. For the same administrative punishment matter, if the higher-level drug supervision and administration has established discretion standards for administrative penalties, the lower-level administration should, in principle, apply these standards directly.
In conclusion, the Rules is conducive to further regulating administrative penalties in drug supervision and management. The Rules also make it clear to relevant enterprises that they should effectively prevent compliance risks by conducting self-supervision, actively fulfilling their social responsibilities and legal obligations, and taking proactive measures to eliminate adverse effects.
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