SCIO briefing on securing market order to support work and production resumption

A press conference was held Tuesday morning to shine light on measures taken by State Administration for Market Regulation, National Medical Products Administration and China National Intellectual Property Administration to support work and production resumption.

China SCIO February 27, 2020

China Review News Agency (Hong Kong):

You just mentioned that the NMPA approved a group of drugs and medical devices for epidemic prevention and control within a short period of time due to the pressing need. How are you sure of the quality of these medicines and medical devices? What measures has the NMPA adopted to strengthen management of medicine and medicinal equipment used for epidemic prevention and control? Thank you.

Yan Jiangying:

This is a very good and important question. Everyone knows that drugs and medical devices are special commodities. We need to double and triple check them for quality and safety. First, we need to check their quality and safety before they go into market. Second, we need to check their quality and safety after they're already in the market. We have launched an emergency approval process. Before they go to market, we firmly adhere to the principle of "safety first, evidence of efficacy, quality assurance and unconventional review." Based on this guiding principle, we uphold the premise of safety and effectiveness, and accelerate review and approval, which is a key procedure before they go to market.

While speeding up review and approval, we are tightening supervision after medicines and medical devices for epidemic prevention and control go to market. NMPA has strengthened supervision especially on emergency medicines and medical devices, as well as drugs used in treatments suggested by the National Health Commission. We have focused our work in the following ways:

First, we strictly enforce a bottom line for quality and safety, and strictly enforce the supervisory responsibilities of related departments in overseeing enterprises fulfilling their responsibilities. We have strengthened supervision and inspection of drugs and medical devices for epidemic prevention and control, especially emergency products which have enjoyed quick approvals. Additionally, we are increasing checks and sampling inspections while strengthening pharmacovigilance. We require manufacturers to organize production in strict accordance with production quality management standards. Released products are strictly controlled. At the same time, we supervise enterprises in strengthening complete quality management including purchasing channels, purchase and sales records, storage and transportation conditions. We have stationed inspectors in pharmaceutical and medical device manufacturing factories and tasked them with overseeing strict quality management to ensure the quality, safety and effectiveness of products.

Second, we have dispatched inspection teams to strengthen supervision of key products for epidemic prevention and control. We have conducted closed cooperation with industrial and information departments and market regulation administrations to reinforce supervision and inspection of designated enterprises, in order to identify problems and solve problems quickly. So far, NMPA has sent 13 working teams in two waves to increase supervision and inspection of drugs and medical devices to be used in epidemic prevention and control alongside local medical products administrations. We are urging enterprises to practice strict self-discipline and ensure product quality and safety.

Third, we are also cracking down on crimes. With the help from authorities in public security, health and market regulation, we have accelerated investigating and prosecution of illegal and criminal acts related to drugs and medical devices in accordance with the law. Criminals will face heavier punishments in accordance with the law. We will do everything we can to ensure medicine and medical device safety during this period.

Next, we will continue to strengthen supervision of the quality and safety of medicine and medical devices while continuing emergency reviews and approval work. Thank you.

Hu Kaihong:

The press conference is hereby concluded. Thanks to the four speakers, and thanks to you all.

Translated and edited by Yin Xing, Zhao Yue, Wang Shuya, Zhou Xin, Xu Shuyuan and Scott Huntsman. In case of any dispute over a discrepancy, the Chinese version is deemed to prevail.

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