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

Economy
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 SCIOUpdated: February 28, 2020

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Speakers:

Tang Jun, vice director of State Administration for Market Regulation

Yan Jiangying, vice director of National Medical Products Administration

He Zhimin, vice director of China National Intellectual Property Administration

Chen Xu, inspector of the Department of Food Operation of State Administration for Market Regulation

Chairperson:

Hu Kaihong, spokesperson of the State Council Information Office

Date:

Feb. 25, 2020

Hu Kaihong:

Ladies and gentlemen, good morning. Welcome to the press conference of Joint Prevention and Control Mechanism of the State Council. Today, we have invited Mr. Tang Jun, vice director of State Administration for Market Regulation (SAMR), Ms. Yan Jiangying, vice director of National Medical Products Administration (NMPA), and Mr. He Zhimin, vice director of China National Intellectual Property Administration (CNIPA). They will explain measures taken to maintain market order and support resumption of work and production. They will also take questions. Also present is Mr. Chen Xu, inspector of the Department of Food Operation of SAMR. Now, I will give the floor to Mr. Tang Jun.

Tang Jun:

Friends from the media, good morning. First, I'd like to express my heartfelt thanks to all of you attending this press conference wearing masks at such a special time. Thank you for your attention and support for the work related to market regulation. Thank you for all your hard work. Now, I will provide a general picture of the measures we've taken to support work resumption. After that, you are welcome to ask questions.

General Secretary Xi Jinping attaches great importance to prevention and control of the COVID-19 epidemic as well as economic and social development. He has emphasized on many occasions that on top of solid epidemic prevention and control work, efforts should be made to fully support and organize various enterprises to resume production and ensure the stability of the industrial chain. At the Central Deployment Work Conference on February 23, General Secretary Xi Jinping made an important speech. He reiterated the position of promoting epidemic prevention and control and resumption of work and production in a coordinately manner. He outlined clear requirements for orderly resumption of work and production. Premier Li Keqiang has also guided enterprises' resumption of work and production extensively. SAMR has resolutely implemented decisions and work arrangements. We maintain a problem-oriented approach and implement precise policy measures. Together with NMPA and CNIPA, SAMR quickly promulgated Ten Policies and Measures to Support the Resumption of Work and Production.

In general, the fact that multiple measures have been taken is the first takeaway. Various functions of market regulation have been integrated to guide the whole regulation process. Multiple coordinated measures have been taken to enhance regulation effects. Second, swift action has been taken. SAMR acted quickly upon receiving the order. On February 15, we introduced ten measures to support the orderly resumption of work and production. Local administrations for market regulation quickly followed with corresponding measures. Third, strong steps have been taken to change governmental functions. Normal procedures have been amended. Regulation methods have been reformed and service measures have been innovated. All these efforts aim to improve the services of market regulation authorities.

These measures mainly cover five aspects. First, online services have been promoted. We are striving to drive reform to a deeper level and improve the "internet +" services model. Enterprise registration, applying for permits for food production and business, requesting qualification certificates for inspection and testing institutions and asking for anti-trust review on concentrations of undertakings can all be conducted online. We aim to make the whole process related to such services able to be completed online. Second, regular procedures have been simplified and streamlined. We've introduced numerous measures to streamline examination and approval procedures so as to reduce time and costs. We simplified the procedures that can be simplified, combined procedures that can be combined, and cut procedures that can be cut. For example, we reduced the time necessary to issue production permits to enterprises resuming or switching production as well as the wait for examination and approval of compulsory certificates. We streamlined procedures to obtain food production and operation permits. Third, urgent issues have been addressed immediately. For enterprises that shifted to production of emergency supplies such as masks and protective suits or producing drugs for epidemic prevention and control and even patent and trademark registrations related to the epidemic, green channels have been established to provide service to them and tackle special and urgent issues. For enterprises qualified for production but unable to submit required documents at present, production permits can be issued on the spot if they pledge to submit the documents later. For some qualified food production and operation enterprises, business licenses can be issued first and on-site checks can be conducted later.

Fourth, costs and burdens have been reduced. Strict measures have been taken to crack down on the collection of arbitrary charges and illegal fees. Based on the previous reduction and exemption of related fees, various certifying bodies and other technical institutes under the SAMR further has reduced technical services fees by 50 percent. Enterprises in Hubei Province, the epicenter of the COVID-19 outbreak, have been exempted from all kinds of verification, calibration, inspection and testing fees. Fifth, technical assistance and support has been carried out. Resumption of work and production requires services related to measurement, standards, certification, inspection and testing. These are the things we do as administrators of market regulation. We must ask enterprises what they need before taking the initiative to provide them with services and help including going directly to the enterprises to provide on-site services.

After the introduction of the ten measures to support resumption of work and production, we went straight to implementation and have already achieved early results. First, we stepped up efforts to facilitate enterprises' resumption of work and production. We have extended licenses for special equipment and renewed licenses by exempting reviews for 87 enterprises affected by the COVID-19 epidemic. A total of 22 inspection and testing institutes in 10 provinces and municipalities were authorized to handle 110 project expansions. Beijing alone has expedited issuance of business licenses and permits for 19 enterprises producing and selling epidemic prevention products. Procedures to apply for permits have been greatly streamlined. Implementation of notification-promise mechanism has made obtaining production permits for five raw materials for producing disinfectants used heavily in epidemic prevention and control period including calcium hypochlorite, sodium hypochlorite, bleaching powder, ethanol and peroxyacetic acid, as well as for two types of fertilizers for spring farming including complex fertilizer and phosphate fertilizer. The procedures took only one day, down from 30 days and 10 days, respectively.

Second, supervision has become more flexible. We are organizing sampling inspections on emergency medical supplies including protective suits produced by designated enterprises. We have strengthened quality supervision while ensuring that sampling inspections don't affect the normal operation of enterprises. During quality inspection of masks, for the small number of enterprises who failed to produce qualified masks, we neither fined them nor stopped their operations. Instead, we organized technical experts to visit the enterprises to help them improve product quality, determine the causes of problems and devise solutions. We strive to guarantee product quality without affecting regular production and operation of enterprises. Many provinces, autonomous regions and municipalities have optimized the management of the enterprise directory, establishing credit repair mechanisms and fostering better conditions for corporate financing. Third, technical support has been robust and timely. SAMR published a list of 55 national-level inspection and testing institutions on medical devices and protective equipment. We have also released information on over 170 provincial-level inspection and testing institutions across the country. As of February 24, 16,765 test applications for masks, protective clothing, and gloves have been accepted, and 11,089 tests have been completed, which effectively provides the necessary technical support to ensure the quality of medical protective equipment.

On the whole, we are serving enterprises heart and soul. We endeavor to understand their troubles, sympathize with their worries and help them solve problems. We will implement future measures with more details and greater effectiveness. Thank you.

Hu Kaihong:

Thank you, Mr. Tang. The floor is now open for questions. Please let us know your outlet when asking.

CCTV:

I have a question for Mr. Tang Jun. You just outlined ten major measures to help enterprises resume production. Do you know of any targeted measures the administration has carried out to solve specific problems enterprises are now encountering? Thank you.

Tang Jun:

Thank you. This is a very good question. It is universally acknowledged that enterprises are facing many difficulties. Our support for the resumption of enterprise operation almost all qualifies as targeted measures tailored to meet the most urgent needs.

First, we have widely encouraged "face-away-from-face" business processing to reduce personnel movement during the period of epidemic prevention and control. In recent years, market supervising authorities have gradually implementing a complete procedure for online business processing. During this period, we have strengthened existing measures and applied them in more regions. We have implemented online processing for the registration of enterprises, issuance of food production license and qualification for inspection and testing institutions.

Second, realizing that administrative licensing and compulsory certification were affecting resumption of operations, we introduced a notification-promise mechanism. Enterprises that have shifted to production of materials related to epidemic prevention and control still need licenses. Generally, it takes some time to file all the necessary paperwork. But now we will approve the production license immediately if the enterprise is well-equipped for production and pledges to produce the required files within a certain period. We have also adopted a special approach for food producers. While maintaining standards to ensure food quality and safety, a few food companies, especially companies with low risk, will get certificates issued before inspection. Other companies already have production licenses that are set to expire. Usually they last five years before you must apply for an extension. We have postponed the extension procedure. These are specific measures targeting difficulties now facing enterprises.

Third, we accelerated the conversion between international and domestic standards to help many export-oriented enterprises resume production faster. Many China's manufacturers export to the international market. Their products produced according to international or foreign standards cannot be sold in China according to existing regulations. So, we streamlined the shift between international standards and domestic standards, tapped their production potential, and supported resumption of foreign trade enterprises.

Fourth, prudent management of a list of enterprises engaging in irregular operations will help repair corporate credit. Some enterprises from across the country are on the anomalous directory. Getting on this list means restrictions for them in realms of governmental procurement, bidding and financing. We have announced that if they correct the thing that got them there, we will conduct credit repair so they can easily go back to normal production.

We have also proposed a series of measures in other aspects in terms of measurement standards, certification and accreditation, inspections and testing. These came about due to specific urgent requests from enterprises, for which we have been consistently proposing solutions like the ones I mentioned. Thank you.

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.

TheCover.cn:

There was a report that remdesivir, a drug developed by Gilead Sciences, Inc. in the U.S., has shown effectiveness in treating COVID-19. What is the patent situation in China? We saw some Chinese pharmaceutical companies claim to produce a generic version of the drug remdesivir. Has the State Intellectual Property Office commented on this? Thank you.

He Zhimin:

Thank you for your question. According to multiple reports, remdesivir is a new drug in development by U.S.-based Gilead Sciences, Inc. It was first used to treat diseases such as Ebola and Middle East respiratory syndrome. This drug has not yet been taken to market in any country in the world and remains in the clinical stage. Some U.S. news outlet reported that remdesivir had shown preliminary effectiveness in treating COVID-19. China has started clinical trials of the drug in several hospitals in Wuhan. Trials are under way, and we won't get the results until April 27. We are paying close attention to the findings of the trials.

According to the current public information, Gilead Sciences, Inc. has applied for eight patents in China related to remdesivir. At present, three patents have been granted and five remain under review. The protection scope of these eight patent applications covers the core structure and similar structure of the compound, crystal form, related manufacturing methods and application.

Medicine is a special commodity crucial for many people's life and health. At the same time, because of the huge required investment, long time and great risk of drug research and development, the industry needs strong intellectual property protection. According to the provisions of the Patent Law of China, after patent right are granted, except for exceptions provided for in the law, no entity or individual may manufacture, use, promise to sell, sell or import a patented products for the purpose of production and operation without the permission of the patent holder. What are the exceptions? They include patented technology for scientific research and test purposes, as well as the import of patented medicine to provide information needed for administrative examination and approval.

Medicine is also special products, whether developed through original research or generics, in that they need strict approval by the regulatory department before they can be put on the market. Pharmaceutical enterprises must produce and market patented products according to law, not only through medicine regulatory authorities, but also while respecting the property rights of patent holders. If a patent holder sees infringement, he or she can bring a lawsuit or submit a request for administrative arbitration. We will protect the legitimate rights and interests of the patent holder within the framework of the Patent Law.

Now that remdesivir is currently in clinical trials, we are quite concerned about its effectiveness and safety. We are also looking forward to the emergence of numerous other medicines that have shown promise in treating COVID-19 including existing medicines. At present, the prevention and control of novel coronavirus pneumonia epidemic has reached the most critical stage. We, along with scientific research workers and pharmaceutical enterprises, should keep the people's safety and health at the top of the agenda and show a strong force of solidarity and cooperation to win the battle. Thank you.

China Business Network:

I have a question on food security, which is closely related to people's lives. During epidemic prevention and control, what preferential measures have market regulation administrations introduced to help food production and operation enterprises resume work in an orderly way? Thank you.

Chen Xu:

Thank you for your question. During the unexpected COVID-19 outbreak, food remains the top concern related to people's daily lives among all the basic needs. According to features and regulatory requirements of food consumption during the epidemic prevention and control period, the SAMR issued a notice deploying market regulation administrations at all levels to strengthen food supervision in key fields, venues and links to ensure food security for all people. It especially encourages food enterprises to actively participate in the "three guarantees" campaign of stabilizing prices, maintaining quality and ensuring supply. Now, nearly half of the 7,000 enterprises participating in the campaign are leading food enterprises above designated size. They are playing an important role in the campaign by contributing greatly in driving the whole food industry to resume work and production in an orderly way to ensure the food supply and maintain market stability.

In addition to ensuring food security, market regulation administrations at all levels are analyzing the real situation of epidemic prevention and control as they leverage their assistance abilities and employ a wide variety of strategies to support food production and operation enterprises in resumption of work. Measures include the following:

First, licensing can be extended. During the period of epidemic prevention and control, if a food production and operation license expires, local administrations for market regulation can extend its validity until the epidemic situation lifts, which is a great convenience for relevant people.

Second, a license can be issued after a food production enterprise makes commitments. During the epidemic prevention and control, local administrations for market regulation can explore and implement a promissory commitment mechanism in combination with food security risk classification management. For new enterprises applying for food production licensing and enterprises applying for a change in food production licensing that normally requires on-site verification, provincial-level market regulation administrations can pilot in accepting promissory commitments from low-risk food enterprises and granting permissions for operation before inspection, which means they issue the licenses for production first, and then conduct on-site inspection within 30 working days.

Third, the whole license application procedure can be done online. Market regulation administrations are harnessing "internet plus" technology to process applications for food production and operation licensing including acceptance, examinations, certification, inquiries and publicity. The administrations are promoting issuance of electronic licenses, which enables enterprises to apply for licensing online and improves efficiency.

Fourth, the licensing approval process can be accelerated. Since implementation of epidemic prevention and control measures, market regulation administrations at all levels have accelerated the approval process of food production and operation licensing to support food enterprises in increasing production, ensuring quality, stabilizing development and overcoming difficulties. This has created good conditions for enterprises to resume work and production.

For the next step, the SAMR will guide and support leading food enterprises to further enhance the effects of the "three guarantees" campaign. Great efforts are being made to expand the role of online platforms in facilitating contactless transactions and promote distribution modes that create a healthier food consumption environment. Since the number of people eating out and purchasing food outside has sharply decreased during the epidemic, offline food enterprises have been encouraged to develop online operations to help offset the loss of offline business. We are encouraging e-commerce platforms to launch more preferential measures to help consumers and merchants using them.

The SAMR will continue to work with all sectors of society to fully prepare for total recovery by promoting innovation and development of the food industry during and after the outbreak. Thank you.

Economic Daily and China Economic Net:

I have a question for Mr. Tang Jun. We understand that the "three guarantees" campaign involves stabilizing price, maintaining quality and ensuring supply. What progress has this campaign achieved so far? What role have participating enterprises played in the fight against the epidemic? Thank you.

Tang Jun:

The "three guarantees" campaign was officially launched on January 29, 2020. Its purpose is to mobilize social resources, especially enterprises and retailers, to maintain market order, ensure supply of epidemic prevention products and guarantee the basic needs of daily life. Since the launch, the action has attracted a robust response. As of February 24, 7,324 enterprises have participated in the action including producers and distributors, e-commerce platforms, shopping malls, supermarkets and franchised convenience stores. Most major enterprises in China are participating in the action, and its effects can be seen in more than 200,000 offline stores covering large, medium and small cities and rural areas. The action has achieved obvious effects.

Market regulation administrations are doing everything they can to stabilize prices. You've probably noticed reports of timely investigation and sanctioning of enterprises marking up the price of masks. As of February 24, more than 4,500 enterprises have been investigated and fined, and over 11,000 cases have been filed alleging price gouging of other medical protective equipment and important commodities for daily life. We work with national and local media to expose such behavior quickly and widely.

But many enterprises are taking active measures and utilizing e-commerce to control prices. E-commerce platforms participating in our action have removed more than 200,000 marked up masks from more than 36,000 stores. Enterprises committed to ensuring quality have been closely checking the quality of goods, strictly controlling purchasing channels, and quickly recalling defective products.

In terms of ensuring supply, many enterprises participating in the "three guarantees" campaign have actively responded to the call to resume work and production. About 98.9 percent of enterprises in the supermarket industry have resumed work and production, and more than 70 percent of enterprises in the food production sector have resumed work and production. E-commerce platforms have helped by strengthening information collection and transaction coordination, timely and accurately connecting supply and demand ends, and effectively guaranteeing supply.

We have seen a lot of promising results since the launch of the campaign. I would like to take this opportunity to ask even more enterprises to participate. The market regulation administrations will work with enterprises to maintain market order and ensure supply of basic commodities. Thank you.

China News Service:

We know that intellectual property pledge financing remains a big concern for small and medium-sized enterprises (SMEs). In these difficult times, what measures will the CNIPA take to support financing and renewal of loans to alleviate corporate financial difficulties and support resumption of work and production? Thank you.

He Zhimin:

Thank you for your question and for bringing attention to the financing difficulties SMEs have experienced. As we all know, many SMEs are indeed facing financing strains due to the epidemic. Solving their financing problems is an important task. Intellectual property pledge financing is an effective way to help SMEs, especially technology-based ones, alleviating capital shortage.

In accordance with decisions and arrangements of the CPC Central Committee and the State Council, CNIPA has actively promoted work on intellectual property pledge financing. In 2019, the total amount of pledge financing of patents and trademarks reached 151.5 billion yuan (US$21.6 billion), which helped nearly 10,000 enterprises solve the problem of capital shortage. After the COVID-19 outbreak, CNIPA studied and implemented the guidelines of General Secretary Xi Jinping and decisions and arrangements of the CPC Central Committee and State Council through a series of concrete measures. These measures include facilitating services on intellectual property-related business, relaxing deadlines and restoring rights, promoting intellectual property pledge financing, providing services on patent information and optimizing window service.

Regarding support for enterprises' intellectual property pledge financing, we are currently focusing on three areas:

First, we have established a green channel for pledge registration. According to the needs of enterprises and banks, we respond immediately and accelerate processing with an aim to finish online registration within one working day. Enterprises producing emergency supplies for epidemic prevention and control can complete procedures instantaneously. We will never allow the registration process to slow down loans to be used to produce supplies for epidemic prevention and control.

Second, we have organized local administrations to investigate pledge demands and available projects. When we understand demands for patent and trademark pledges related to epidemic prevention and control, as well as the repayment abilities of the enterprises with available projects, we can carry out door-to-door services and make better use of relevant policy tools to actively coordinate the bank's loan dispersal and renewal to those enterprises.

Third, we are increasing policy integration and fostering innovation. Where conditions permit, we encourage local administrations to integrate various support policies such as loan discounts, risk compensation, insurance and subsidies. We also encourage them to innovate methods of the internet and new media project aligning and of policy publicity, and to bring IPR's role in increasing credit and loans to enterprises into full play, thus supporting enterprises' resumption of work and production.

We are happy to find that some local administrations have taken strong measures to promote intellectual property pledge financing. Their efforts are winning great acclaim from relevant enterprises and the whole society. For example, Guangdong Provincial Intellectual Property Administration issued a notice demanding authorities enhance intellectual property pledge financing work to help enterprises to overcome current difficulties. Accordingly, Dongguan City of Guangdong assumed a lead role in support of enterprises. It loaned out 15 million yuan (US$2.13 million) to a medical enterprise with three utility model patents as collateral, greatly relieving its operational pressure and expanding its production capacity. The Intellectual Property Office of Jiangsu Province also has boosted intellectual property pledge financing work. They launched a special program which allowed 37 enterprises to receive pledge loans of 114 million yuan (US$16.25 million) since the epidemic outbreak. There are also many other examples, but I will not list them one by one.

Next, CNIPA will strengthen coordination with local authorities to actively promote useful experience and effective practices. We will fully support qualified enterprises in need of quick financing and contribute to helping them resume and expand production. Thank you.

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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