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中国疫苗行业十年来的发展:从药品监管科学的角度。

The development of China's vaccine industry in the past decade: the perspective from drug regulatory science.

机构信息

School of Business Administration, Shenyang Pharmaceutical University, Shenyang, P.R. China.

National Institute for Food and Drug Control, Beijing, P.R. China.

出版信息

Hum Vaccin Immunother. 2021 Dec 2;17(12):5666-5672. doi: 10.1080/21645515.2021.2002640.

DOI:10.1080/21645515.2021.2002640
PMID:34856877
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8903904/
Abstract

Analysis of the batch issued data of Chinese vaccines from 2011 to 2020 showed that the average annual dose of vaccines in China was 769.66 million doses, and the overall production was stable. Fourteen new vaccines were added, six of which were developed in China. The batch issued dose of national immunization program (NIP) vaccine was stable with slightly decreased, while the non-NIP vaccine showed an increasing trend. The development trend of combined vaccine increased significantly. Regulatory science in China's development, promoted the China's vaccine regulation the perfection of legal system, and the steady improvement of vaccine quality and standards, and the gradual maturity of the construction of lot release system. With the goal of being safe, effective, reasonable, and accessible, China's vaccines encourage the research and development of new technologies and emergency vaccines to constantly improve the level of public health.

摘要

分析 2011 年至 2020 年中国疫苗批签发数据显示,中国疫苗年平均接种剂次为 7.6966 亿剂次,整体生产较为稳定。新增 14 种疫苗,其中 6 种为中国自主研发。国家免疫规划疫苗(NIP)批签发剂量稳定略有下降,而非 NIP 疫苗呈上升趋势。联合疫苗的发展趋势显著增加。中国监管科学的发展,推动了中国疫苗监管法律法规体系的完善,疫苗质量和标准的稳步提高,以及批签发体系建设的逐步成熟。中国疫苗以安全、有效、合理、可及为目标,鼓励新技术和应急疫苗的研发,不断提高公共卫生水平。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fcce/8903904/597a8fb160be/KHVI_A_2002640_F0003_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fcce/8903904/8e2bbb6fe8c3/KHVI_A_2002640_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fcce/8903904/ea53417f8871/KHVI_A_2002640_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fcce/8903904/597a8fb160be/KHVI_A_2002640_F0003_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fcce/8903904/8e2bbb6fe8c3/KHVI_A_2002640_F0001_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fcce/8903904/ea53417f8871/KHVI_A_2002640_F0002_OC.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fcce/8903904/597a8fb160be/KHVI_A_2002640_F0003_OC.jpg

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