SCIO briefing on strengthening drug regulation to ensure drug safety for the public
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E-mail China.org.cn, July 28, 2023
Red Star News:
China has adjusted its COVID-19 prevention and control policy, now managing it with measures against Class B infectious diseases. What deployments has the NMPA made in terms of service guarantee for the new stage of COVID-19 prevention and control work and strengthening the quality supervision of COVID-19-related medicine and equipment? Thank you.
Jiao Hong:
Thank you for your question. The NMPA attaches great importance to the review and approval of drugs and medical devices and product quality supervision work involved in COVID-19 prevention and control. I would like to invite Mr. Huang Guo to provide you with the relevant details.
Huang Guo:
Thank you for your question. Since the COVID-19 outbreak, drug regulatory authorities at all levels have thoroughly implemented the decisions and deployments of the CPC Central Committee and the State Council, remained committed to putting the people and their lives first, maintained a state of readiness, adhered to a science-based approach, gone all out to guide and promote the R&D and marketing of vaccines, therapeutic drugs and other products, and spared no effort to do a good job in the quality supervision of COVID-19-related drugs and medical devices. At present, we are continuing to do a good job in related work according to changes in the COVID-19 prevention and control situation and the requirements of measures against Class B infectious diseases. I would like to introduce two aspects:
For one thing, we will continue to provide technical guidance and services for the research and development (R&D) of medicines and vaccines. We will summarize the previous emergency assessment and approval experience, continue to mobilize our best efforts, combine research and assessment, support innovation and R&D, and strive to further enrich our toolbox for combating the pandemic. Previously, the NMPA has successively approved the use or addition of indications of 15 drugs for COVID-19 treatment through a special approval procedure: six chemical medicines (four homegrown ones and two imported ones), two biological products, and three traditional Chinese medicine (TCM) drugs and four TCM prescriptions. We have also given conditional market approvals for five COVID-19 vaccines, among which three have been listed by the WHO for emergency use. Furthermore, we have given emergency approval for China's first homegrown extracorporeal membrane oxygenation (ECMO) device and 151 COVID-19 testing reagents. Next, on the basis of continuously encouraging innovation and R&D, we will urge relevant enterprises to conduct post-marketing studies in accordance with requirements.
For another, we will continue to strengthen the quality regulation of COVID-19 medicines and medical equipment. For homegrown COVID-19 drugs, we have introduced the management requirements of implementing enterprise-specific policies and product-specific registration. We will continue to conduct supervision and inspection of all the enterprises that are producing COVID-19 vaccines with conditional market approval and for emergency use, sending inspectors to all the factories and ensuring tests for lot release. Moreover, we will continue to enhance random inspection and adverse reaction monitoring of other pandemic-related products, including medicines and medical equipment, so as to make sure that the products are safe and effective, and quality controllable. This is the main responsibility that the drug regulatory departments at all levels must constantly focus on. Thank you.
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