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E-mail China.org.cn, October 16, 2024
Jimu News:
The quality of pharmaceuticals is directly related to public health and safety. We noticed that the NMPA is implementing a drug safety consolidation and enhancement campaign. Could you provide an update on its progress and effectiveness? And how does the NMPA plan to further strengthen pharmaceutical quality and safety supervision? Thank you.
Li Li:
Thank you for your interest in the drug safety consolidation and enhancement campaign. I would like to invite Mr. Zhao to provide more details.
Zhao Junning:
I will answer this question. The NMPA places great emphasis on drug safety, consistently working to purify the pharmaceutical market and maintain a stable and improving drug safety landscape. Since June 2023, the NMPA has been implementing a one-and-a-half-year drug safety consolidation and enhancement campaign, aimed at solidifying the foundation of drug safety and protecting public health.
First, we are focused on key issues and are actively resolving risks and hidden dangers. By targeting key products, key processes, key regions and key enterprises, we have conducted special inspections of pharmaceutical operations and uses, special inspections of special medicines, special checks on delegated manufacturing for medical device registrants, supervisory spot checks of clinical trials for medical devices, and special inspections of hair dye cosmetics. We aim to identify and resolve risks and hidden dangers through multiple channels and dimensions, utilizing our capabilities for risk warning, identification and resolution, and taking effective measures to address potential drug safety risks promptly.
Second, we are cracking down on major cases and strictly punishing illegal activities. We are using means such as exposing typical cases and publishing lists of those committing serious violations of law and trust. We ensure that penalties are enforced against individuals responsible for illegal acts, implement joint punishments, ban individuals from the industry, and prohibit certain practices, all in a concerted effort to ensure the stability of drug safety.
Third, we will improve institutional mechanisms and comprehensively enhance regulatory capabilities. We are advancing the implementation of local management responsibilities, strengthening departmental regulatory responsibilities, and reinforcing corporate principal responsibilities to ensure comprehensive drug safety safety. The NMPA, in conjunction with the State Administration for Market Regulation (SAMR), has issued the Guidance on Strengthening Cross-Regional and Multi-Level Drug Regulatory Collaboration, which enhances the coordination among national, provincial, city and county-level drug regulatory departments throughout the entire lifecycle of drugs. In collaboration with the Ministry of Public Security, the NMPA has jointly issued the Guidelines for the Inspection and Determination of Suspected Criminal Cases in the Pharmaceutical Field to promote effective integration of administrative and criminal enforcement efforts. A total of 142 city and county-level drug regulatory departments have been designated as grassroots contact points, achieving a demonstrative and leading effect. Local drug regulatory departments are actively developing teams of township pharmaceutical safety co-managers and rural pharmaceutical safety information officers, extending drug regulatory oversight to townships and rural areas, and enhancing comprehensive governance capabilities at the primary level.
Next, the NMPA will continue to focus on key tasks of the drug safety consolidation and enhancement campaign. We will intensify our efforts, focus on investigating a number of major cases, and strictly punish illegal and non-compliant behaviors. We will also strengthen the investigation and resolution of risks and hidden dangers to solidify the foundation of drug safety. Thank you.
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