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National Medical Products Administration Supervision Team Visits Shisi Pharmaceutical to Inspect and Provide Guidance on Epidemic Prevention and Control Work

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Group News

发布时间：2020-02-10

【概要描述】 On the morning of February 8, a supervisory team from the National Medical Products Administration, led by Su Lei, Director of the Retired Cadres Bureau of the NMPA, and comprising four members, visited Shisi Pharmaceutical for an on-site inspection, accompanied by relevant officials from the Hebei Provincial Bureau. The team conducted a supervisory review of the Hebei Provincial Bureau’s implementation of the NMPA’s relevant requirements, fulfillment of local regulatory responsibilities, and strengthening of oversight and inspection of manufacturers of medical protective suits and pharmaceutical products. The NMPA supervisory team then entered Shisi Pharmaceutical’s oral solid dosage production workshop to thoroughly examine the production and quality management of the anti-epidemic drug, Arbidol Hydrochloride Capsules. Su Xuejun, Chairman of Shisi Pharmaceutical, provided a detailed briefing to the team on the company’s efforts in epidemic prevention and control.

National Medical Products Administration Supervision Team Visits Shisi Pharmaceutical to Inspect and Provide Guidance on Epidemic Prevention and Control Work

On the morning of February 8, a supervisory team from the National Medical Products Administration, led by Su Lei, Director of the Retired Cadres Bureau of the NMPA, and comprising four members, visited Shisi Pharmaceutical for an on-site inspection, accompanied by relevant officials from the Hebei Provincial Medical Products Administration. The team conducted a supervisory review of the Hebei Provincial Administration’s implementation of the NMPA’s relevant requirements, fulfillment of its local regulatory responsibilities, and strengthening of oversight and inspection of manufacturers of medical protective suits and pharmaceuticals.

A supervisory team from the National Medical Products Administration conducted an on-site inspection of the oral solid dosage production workshop at Shisi Pharmaceutical, thoroughly examining the production and quality management of the antiviral drug abidor hydrochloride capsules. Su Xuejun, Chairman of Shisi Pharmaceutical, provided a detailed briefing to the team on the company’s efforts in epidemic prevention and control, emergency drug production and stockpiling, and the implementation of manufacturers’ primary responsibility for product quality.

The National Medical Products Administration’s supervisory team expressed its heartfelt gratitude to the enterprise 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. During this critical period, ensuring the quality and safety of medical devices and pharmaceutical products used for epidemic protection is the top priority of current regulatory work. Drug regulatory authorities must elevate their political awareness, rigorously adhere to the “four strictest” requirements, earnestly fulfill local responsibilities and departmental regulatory duties, and urge enterprises to assume their principal responsibilities. They should continuously strengthen oversight over the production and distribution of drugs and medical devices, with a particular focus on conducting comprehensive inspections and supervision of manufacturers of epidemic-prevention-related pharmaceuticals, medical protective suits, and medical protective masks, as well as targeted inspections of operators engaged in the sale of such products. At the same time, they must intensify random sampling and testing, and enhance monitoring of adverse reactions (events), to ensure product quality and safety and resolutely prevent substandard or counterfeit products from entering the frontline of medical protection. Furthermore, they must severely crack down on illegal activities involving the manufacture and sale of fake and substandard drugs and medical devices, promptly and strictly investigating and prosecuting cases in accordance with the law, with heavier penalties and expedited procedures; where criminal offenses are suspected, leads must be promptly reported to public security organs and cases transferred without delay, and such cases should, when necessary, be designated as priority investigations under direct supervision. It is imperative to uphold the principle of accountability for one’s own jurisdiction and to fully discharge that responsibility, resolutely implementing quality oversight duties while actively cooperating with the Ministry of Industry and Information Technology and the National Health Commission to ensure the production and supply of epidemic-prevention medical devices and to establish, at an early stage, an emergency review-and-release mechanism for these products. Finally, the system of seeking instructions and submitting reports must be conscientiously implemented, with any major issues or recommendations encountered in the course of work to be promptly reported to the National Medical Products Administration.

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