NMPA: Multiple measures to meet drug, medical device demand of COVID-19 epidemic prevention, control

The leaders of the Joint Prevention and Control Mechanism of the State Council held a press conference on Feb 25, informing media reporters of the maintenance of market order and the support for resumption of production. The conference included a question and answer session.

Yan Jiangying, deputy commissioner of the National Medical Products Administration (NMPA), attended the press conference and said that the NMPA immediately initiated emergency approval passage for drug and medical devices when the COVID-19 epidemic broke out.

The provincial-level drug regulatory departments also guided enterprises to properly arrange production and to increase production capacity to fully support clinical supply.

By Feb 24, daily output of medical protective gowns and surgical masks had reached 330,000 and 844,000 respectively, and nucleic acid test kits for 1.7 million people and antibody test kits for 350,000 people were produced per day.

Following the State Council's steps to strengthen science-based epidemic prevention and control and to guide enterprises in resumption of production, the State Administration for Market Regulation, jointly with the NMPA and the National Intellectual Property Administration, fulfilled their duties and jointly released Ten Measures to Support Resumption of Production, aiming to solve enterprises' practical problems arising during the work resumption period. The Measures clearly demand an emergency approval passage to be established for drug and medical devices needed for combating the epidemic.

At the conference, Yan said that the NMPA has taken a variety of measures to guarantee critical material demands for epidemic prevention and control as well as drug and medical device supplies.

The administration first made emergency drug and medical device approval plans and established an approval mechanism and then set up a specialized expert team.

The review and approval process for medical products were then accelerated to meet anti-epidemic demands. Drugs were reviewed and approved quickly for registration.

Special measures were taken on registration, production license and testing of medical devices including medical face masks and medical protective clothing, which involved combining some approval procedures.

Emergency approval procedures were adopted for enterprises that temporarily switched to produce medical devices and they were given medical device registration certificate and production license in accordance with the law.

In the next step, the NMPA gave timely support to enterprises and help them to increase production. Drug regulatory departments strengthened their guidance of enterprises and launched "one-on-one" service to provide them with consultations, technical support and policy guidance.

In terms of drugs needed in anti-epidemic prevention and control, all provincial-level drug regulatory departments supported enterprises to arrange production scientifically and make full use of their capacity.

To relieve enterprises' burden, registration fees are waived for COVID-19-related medical devices in emergency approval stages and for drugs entering the special approval procedures related to treatment and prevention of the disease.

According to Yan, the NMPA has approved five new drugs including Remdesivir and Favipirivir for emergency clinical trials of the COVID-19 epidemic.

Nucleic acid reagent test kits produced by seven enterprises had been approved during the early days when the epidemic broke out and again on Feb 22 to meet demand for quick testing on the front line. The NMPA approved three more reagent test kits, among which two are antibody reagent test kits based on the colloidal gold technique and one is a nucleic acid reagent test kit based on isothermal amplification on a disk chip.

By Feb 24, 134 medical device registration certificates for medical protective clothing were given in China, of which 93 were issued through the emergency approval procedures. Eighty-four registration certificates for medical protective face masks and 225 for surgical face masks were approved with 21 and 67 respectively issued through emergency approval. As for single-use medical face masks, 396 registration certificates were issued and 65 were given fast approval.

Yan pointed out that the NMPA continuously sticks to these principles for emergency approval: Safety is the bottom line, effectiveness must be proved, and quality must be guaranteed while launching expedited review and approval. In addition, drugs and medical devices approved through emergency procedures will still be stringently monitored and managed after they enter the market.

Monitoring of drugs listed in the diagnosis and treatment plan of the National Health Commission will also be strengthened.

She explained the principles from three aspects.

First, quality is the bottom line. NMPA will strengthen supervision and inspection of drug and medical devices for epidemic prevention and control. An on-site supervision mechanism will be implemented in enterprises that produce such equipment as medical protective clothing.

Second, inspection teams have been dispatched to improve supervision and management of key products for epidemic prevention and control. Cooperation between the NMPA and industry and information technology and market regulation departments will be deepened to strengthen supervision and inspection of the designated enterprises.

So far, the administration has sent 13 teams in two groups to work with local drug regulatory departments on supervision and inspection of drug and medical devices needed in epidemic prevention and control. Enterprises shall strengthen self-discipline to guarantee quality and safety of their products.

Third, there will be serious crackdown on criminal behavior. The administration will actively work together with public security, health and market regulation departments to inspect and handle drug and medical device-related criminal activities stringently, harshly and quickly.

She also stressed that the NMPA will continue to improve emergency approval of drug and medical devices used in epidemic prevention and control and at the same time urge provincial-level drug regulatory departments to implement related deployments by promoting guidance, service and supervision of enterprises to switch to and expand production of relevant products. Meanwhile, the administration will also support enterprises to resume production and to guarantee quality and safety of medical devices used in epidemic prevention and control.