基于2021年国家药品抽检探索性研究结果，针对尚不显著影响药品质量安全且非药品生产企业主观故意造成的一般性风险组织相关药品生产企业自行排查整改的工作是我国药品监管的创新性策略。2021年的问题排查有效率达80.80%，整改和预防率高达96.2%，生产企业采取召回措施的风险控制率为9.2%；暂停相关品种的生产或销售的风险控制率为13.2%，整改措施包括加强生产过程控制、修订内控标准、加强原辅包质量控制等。多管齐下的整改措施有效促进了药品质量的提升，取得了令人满意的成果。同时，也存在风险排查失败等情况，建议国家药品抽检承检机构进一步提升探索性研究的科学性和靶向性；建议生产企业正确认识该项工作，运用多种手段进行风险排查；建议药监部门加强对生产企业的督促、指导和帮扶，促进生产企业针对相关风险积极认真开展排查并切实整改到位，夯实药品质量安全的主体责任。

Based on the results of exploratory research of national drug sampling and testing in 2021, it was an innovative strategy of China's drug supervision to organize relevant drug manufacturers to investigate and rectify the general risks that did not significantly affect the quality and safety of drugs and are not caused by their subjective intention. In 2021, the effective rate of troubleshooting was 80.80%, and the rectification and prevention rate was as high as 96.2%. The risk control rate of manufacturers taking recall measures was 9.2%. The risk control rate of suspending the manufacture or sale of related varieties was 13.2%. The rectification measures included strengthening manufacturing process control, revising internal control standards, and strengthening the quality of raw materials, excipients and packaging materials control. The multi-pronged rectification measures had effectively promoted the improvement of drug quality and achieved satisfactory results. At the same time, there were also failures in risk investigation. It is suggested that the national drug sampling and testing agency should further improve the scientific and targeted nature of exploratory research; the manufacturers should correctly understand this work, and conduct risk investigations through various means; the regulatory authorities should strengthen the supervision, guidance and assistance to the manufacturers, and promote them to actively and earnestly carry out investigations and rectifications in place of relevant risks, so as to consolidate the main responsibility of drug quality and safety

R927.1