(Combating new crown pneumonia) China's State Food and Drug Administration opens green channel for emergency approval of drugs and medical devices
China News Service, Beijing, February 25 (Wang Qingkai), Deputy Director of the State Administration of Drug Administration of China, Yan Jiangying, said at a press conference of the joint prevention and control mechanism of the State Council on the 25th that in order to protect the emergency prevention and control materials needs and epidemic prevention drugs and medical equipment The State Administration of Drug Administration has opened up a green channel for emergency approval of medicines and medical devices.
Yan Jiangying introduced that the State Food and Drug Administration has formulated a work plan for emergency approval of drugs and medical devices. Establish relevant review and approval work mechanisms, set up special expert groups, and carry out scientific and orderly emergency review and approval of drugs and medical devices. At the same time, the provincial drug supervision and administration department is deployed to support and encourage relevant drug and medical device manufacturing enterprises to urgently arrange production and expand production capacity.
At the same time, the State Food and Drug Administration has speeded up the review and approval process to promote products to market as soon as possible. Yan Jiangying said that the application for drug registration for epidemic prevention and control must be reviewed and approved on the basis of ensuring product safety and effectiveness. Implement special measures for medical device product registration, production license, inspection and testing, and merge approval processes. For enterprises that convert medical devices into products, emergency approval is implemented, and medical device registration certificates and production licenses are processed in accordance with the law.
Yan Jiangying said that the State Drug Administration provided timely services to enterprises and expanded production capacity. At present, a special working group has been established to provide "one-on-one" services to drug and medical device manufacturing enterprises for epidemic prevention and control, providing full-course consultation, technical support and policy guidance. For production enterprises to switch to emergency supplies, the approval procedures for production qualifications shall be simplified, and the urgent inspection and testing procedures shall be initiated. At the same time, part of the self-inspection report of the recognized enterprise, after confirming on-site confirmation of the enterprise that meets the permit conditions, immediately handles product registration and issues a production license. For the drugs needed for epidemic prevention and control, the provincial drug supervision and administration departments guide the enterprises to reasonably arrange production and fully release production capacity.
Reduce and exempt business registration fees and reduce business burden. Yan Jiangying said that medical device registration fees are waived for entering the emergency approval process for medical devices and for prevention and control products related to new crown pneumonia. Drug registration fees are waived for drugs that enter special approval procedures and are related to the treatment and prevention of new coronary pneumonia. (Finish)