SCIO briefing on securing market order to support work and production resumption
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E-mail China SCIO, February 27, 2020
China Daily:
We have a question about the "green channel" for administrative licenses related to medicines and equipment for the epidemic in the ten policies and measures. As you established this green channel for administrative licensing, what measures did the National Medical Products Administration take and what are they doing now? Thank you.
Yan Jiangying:
Thank you for your question. This is another very important issue. As we all know, medicines and medical devices are significant players in prevention and control of the epidemic. Since the outbreak, the National Medical Products Administration has fully implemented instructions from General Secretary Xi Jinping as well as arrangements from the leading group of the Communist Party of China (CPC) Central Committee on the prevention and control of the novel coronavirus outbreak and met requirements of the joint prevention and control mechanism of the State Council. Epidemic prevention and control are our top priority. We quickly opened a green channel to quickly approve medicines and medical devices to guarantee supply of materials, medicines and medical devices for epidemic prevention and control. The major measures are as follows:
First, relevant policies go effective immediately and work plans for fast approval of medicines and medical devices are developed quickly. An expedited working mechanism for examination and approval of medicines has been established and a special expert group for examination and approval of medicines and medical devices has been organized to ensure emergency examination and approval of medicines and medical devices still happen in a scientific and orderly manner. At the same time, we order provincial medicines regulatory bodies to support and encourage companies involved in producing medicine and medical equipment to quickly resume production and expand capacity.
Second, review and approval procedures are being accelerated, so products related to epidemic prevention can be released as quickly as possible. Registration of medicines used for epidemic prevention and control is being expedited while ensuring product safety and effectiveness. Special measures for the registration, production licensing, inspections and testing of medical products such as medical masks and medical protective clothing have been carried out. Approval processes have also been merged. For enterprises that shift to production of medical equipment, we have implemented emergency approval measures to deliver medical device registration certificates and production licenses lawfully while meeting the urgency of epidemic prevention. In the early stages, the National Medical Products Administration approved five new drugs including remdesivir and favipiravir for clinical trials. We also approved the nucleic acid diagnostic reagents produced by seven companies. Another three diagnostic products were approved on February 22. These three products included two diagnostic reagent for antibody (colloidal gold) and one nucleic acid detection reagent (isothermal amplification chip). The products of these three companies help provide rapid detection. By February 24, we issued a total of 134 registration certificates for medical protective clothing and medical devices, of which 93 were urgently approved during the epidemic prevention period. Of 84 registration certificates for medical protective masks, 21 were approved through emergency response. Of 225 medical surgical mask registration certificates, 67 were expedited. And 65 of 396 single-use medical mask registration certificates were issued through the emergency channel.
Third, we are providing timely support for enterprises and helping expand production capacity. Medical supervision authorities are strengthening guidance of enterprises through organization of a special working group. One-on-one service, full consultation, technical support and policy guidance will be provided to pharmaceutical and medical device manufacturers involved in epidemic prevention and control. For emergency supplies such as masks and protective suits produced by enterprises shifting production, the approval procedure for production qualification has been simplified. Inspection, the product registration certificate and production licensing has been integrated, and a fast inspection and testing procedure is being adopted. Meanwhile, we are also temporarily approving some self-inspection reports from enterprises. After on-site confirmation of the qualified enterprises, we immediately proceed to product registration and issuance of a production license. As for medicals supplies for epidemic prevention and control, provincial pharmaceutical regulatory departments have guided enterprises to arrange production to unleash production capacity and guarantee clinical supplies. As of February 24, daily production of medical protective suits, medical masks, nucleic acid detection kits and antibody detection kits reached 330,000, 844,000, 1.7 million and 350,000 per day, respectively.
Fourth, we have reduced registration fees in an effort to lift burdens on enterprises. We are exempting registration fees for coronavirus prevention and control products undergoing the emergency approval process for medical devices. The exemption also covers the registration fee for coronavirus treatment and prevention medicines in the special drug approval process.
Next, the National Medical Products Administration will put into action of the guiding principles from the important speech by General Secretary Xi Jinping at the meeting to advance the work on coordinating the prevention and control of the COVID-19 and economic and social development and start enforcing requirements to resume production. We will focus on the following tasks: First, we will speed up emergency examination and approval of medical and pharmaceutical equipment for epidemic prevention and control. Second, we will ensure provincial drug supervision and administration departments thoroughly implement requirements for epidemic prevention and control, strengthen guidance, serve and supervise enterprises performing transferred or expanded production, vigorously support enterprises in resuming production, and fully ensure the quality and safety of the medical devices needed for epidemic prevention and control. Thank you.
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