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The National Medical Products Administration’s supervision team visited Shisi Pharmaceutical to inspect and guide its epidemic prevention and control efforts.

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Group News

Time：2020-02-10

On the morning of February 8, a four-member supervision team from the National Medical Products Administration (NMPA), led by Su Lei, Director of the Old Cadres Division of the NMPA, accompanied by relevant officials from the Hebei Provincial Bureau, visited Shisi Pharmaceutical for an on-site inspection. The team conducted a supervisory review of the Hebei Provincial Bureau’s implementation of the NMPA’s requirements, fulfillment of local regulatory responsibilities, and enhancement of oversight and inspection of medical protective clothing and pharmaceutical manufacturers. The NMPA supervision team went deep into the oral solid dosage production workshop of Shisi Pharmaceutical, carefully examining the production and quality management practices for the antiviral drug abidor hydrochloride capsules. Su Xuejun, Chairman of Shisi Pharmaceutical, provided the supervision team with a detailed report on the company’s efforts in epidemic prevention and control.

The National Medical Products Administration’s supervision team visited Shisi Pharmaceutical to inspect and guide its epidemic prevention and control efforts.

On the morning of February 8, a four-member supervision team from the National Medical Products Administration (NMPA), led by Su Lei, Director of the Department for Retired Cadres at the NMPA, accompanied by relevant officials from the Hebei Provincial Bureau, visited Shisi Pharmaceutical for an on-site inspection. The team conducted a supervisory review of the Hebei Provincial Bureau’s implementation of the NMPA’s requirements, fulfillment of its local regulatory responsibilities, and enhancement of oversight and inspection of medical protective clothing and pharmaceutical manufacturing enterprises.

A delegation from the National Medical Products Administration’s supervision team visited the oral solid dosage production workshop of Shisi Pharmaceutical, where they carefully examined the production and quality management practices for the antiviral drug abidor hydrochloride capsules. Su Xuejun, Chairman of Shisi Pharmaceutical, briefed the supervision team in detail on the company’s efforts in epidemic prevention and control, emergency drug production and stockpiling, and the implementation of the primary responsibility for quality assurance by pharmaceutical manufacturers.

The National Medical Products Administration’s supervision team expressed heartfelt gratitude to the enterprises for overcoming difficulties, working overtime to ramp up production, and effectively ensuring market supply.

The supervisory team pointed out that the Party Central Committee attaches great importance to epidemic prevention and control work. During this critical period of epidemic prevention, ensuring the quality and safety of medical devices and pharmaceutical products for epidemic protection has become the top priority of current regulatory efforts. Drug regulatory authorities must raise their political awareness, strictly adhere to the “four strictest” requirements, earnestly implement local responsibilities and departmental regulatory duties, and urge enterprises to fulfill their principal responsibilities. They should continuously strengthen supervision over the production and distribution links of drugs and medical devices, with a particular focus on comprehensive inspections and oversight of manufacturers of drugs related to epidemic prevention, medical protective suits, and medical protective masks. Targeted inspections and oversight should also be conducted on businesses engaged in the distribution of drugs and medical devices related to epidemic prevention. Enhanced monitoring through spot checks and adverse reaction (event) surveillance is essential to ensure product quality and safety and to resolutely prevent substandard or counterfeit products from reaching the frontline of medical protection. Authorities must firmly crack down on illegal activities involving the manufacture and sale of fake and substandard drugs and medical devices, pursuing such cases with utmost severity, speed, and rigor according to law. In cases involving suspected criminal activities, relevant leads must be promptly reported to public security organs and cases transferred accordingly; where necessary, these cases should be designated as key cases under special supervision and investigation. We must uphold the principle of taking responsibility for our own jurisdictions and fulfilling those responsibilities diligently, resolutely implementing quality regulatory duties and actively cooperating with the Ministry of Industry and Information Technology and the health authorities to ensure the production and supply of epidemic prevention medical devices, and establishing an emergency review and release mechanism for such products at an early stage. We must conscientiously implement the system of requesting instructions and reporting, promptly reporting any major issues or suggestions encountered in our work to the National Medical Products Administration.

Keywords:

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