SCIO briefing on strengthening drug regulation to ensure drug safety for the public
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E-mail China.org.cn, July 28, 2023
The Poster News APP:
Last year, the NMPA launched a special campaign to guarantee drug safety and released a slew of typical cases. At present, what's the drug safety situation in our country? What are the priorities for strengthening drug safety supervision in the next step? Thank you.
Jiao Hong:
Thank you very much for your concern. We all know that we should hold the bottom line to guarantee security and pursue the superior line to promote development. Security is the prerequisite and foundation of development. Here, Mr. Xu will give you more information on this topic.
Xu Jinghe:
Thanks for your concern. Since 2022, the NMPA has earnestly implemented General Secretary Xi Jinping's important instructions on drug safety and launched a one-year thorough campaign to guarantee drug safety following the four most rigorous standards. Last year, 153,600 criminal cases related to medicines, cosmetics, and medical equipment were investigated and punished, and those suspected of committing crimes were promptly transferred to public security organs for investigation according to the law. The NMPA released four batches of 32 typical cases and gave particular supervision over the handling of 29 major cases related to medicines and medical equipment together with the Ministry of Public Security (MPS) and the Supreme People's Procuratorate (SPP) so as to use the cases to explain the law and provide warnings, which effectively ensured the overall stability of the drug safety situation.
In order to constantly and deeply implement General Secretary Xi Jinping's important instructions on drug safety and the deployment and requirement of the education campaign, we summed up our experience of the special campaign on drug safety and carried out another one-and-a-half-year upgrading activity on drug safety this June, focusing on preventing risks, investigating and handling cases, and improving capabilities. By doing so, we have strived to maintain a stable and positive situation in the field of drug safety and resolutely safeguard the health rights and interests of the people. The upgrading activity mainly includes the following three aspects.
The first aspect involves a comprehensive investigation and diffuse of potential risks. We adhere to risk management and keep regulation ahead of risks. First, we guarantee drug safety at the source. We strictly control market access, strengthen the connection between acceptance, inspection, examination, approval, and other sectors, urge enterprises to implement the main responsibility of quality and safety, and help them further enhance the awareness of compliance, the rule of law, and risk. Second, we improve the pertinence, targeting, and effectiveness of our risk and hidden danger investigations. We focus on key products, key links, key objects, and key areas and thoroughly investigate risks and hidden dangers through multi-channel and multi-dimensional measures. Third we resolve safety risks according to the law in a timely manner. For enterprises with high risk or that have been found to have more problems previously, we increase on-site supervision, including unannounced and secret inquiries and inspections, and endeavor to provide more effort to rectify illegal behavior in key areas, such as medical beauty drugs and medical devices.
Second, we crack down on violations of laws and regulations. We have continued to intensify the investigation and handling of illegal cases so that those who violate the law will pay the due price. First, we constantly promote the investigation and handling of illegal cases. We punish both illegal enterprises and the persons in charge, improve the system of supervision of major cases handling, expose typical cases, and release the names of those who partake in illegal and dishonest practices to the public. Joint punishment, industry banning, barred hiring, and other punitive measures have been taken. Second, we constantly strengthen coordination. We increase interconnection among state, provincial, municipal, and county-level drug regulatory departments to eliminate regulatory blind spots and regions. Third, we intensify trans-departmental investigations and case handling. We work with public security organs, procuratorial organs, and people's courts to improve the system to connect administrative law enforcement with criminal justice, further strengthen the linkage between relevant departments, and establish and improve our trans-departmental risk consultation system.
Third, we continuously improve supervision capability. We comprehensively strengthen our supervision capabilities on drug safety and vigorously improve the supervision efficiency. First, we have strengthened institutional building. We have accelerated making and amending relevant laws and regulations and promote the revision of the applicable rules for the administrative punishment of cases relating to medicine. Second, we constantly optimize the supervision system. We perfect the quality management system for drug inspection, promote the integration of inspections and audits, and improve the pharmacovigilance system and its capacity, as well as issue guidelines on accelerating the smart regulation for drug safety at the provincial level. Third we lay a solid foundation for grass-roots supervision. We strengthen the drug supervision force in municipal and county-level market supervision departments and enhance professional law enforcement capabilities. We also actively increase the employment of township drug safety coordinators and drug safety information staff in villages, investigate and defuse rural drug safety risks, and intensify the investigation and handling of rural drug safety cases so as to pragmatically strengthen township and rural drug supervision. Thank you.
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