基于2021年國家藥品抽檢探索性研究結(jié)果，針對尚不顯著影響藥品質(zhì)量安全且非藥品生產(chǎn)企業(yè)主觀故意造成的一般性風險組織相關(guān)藥品生產(chǎn)企業(yè)自行排查整改的工作是我國藥品監(jiān)管的創(chuàng)新性策略。2021年的問題排查有效率達80.80%，整改和預(yù)防率高達96.2%，生產(chǎn)企業(yè)采取召回措施的風險控制率為9.2%；暫停相關(guān)品種的生產(chǎn)或銷售的風險控制率為13.2%，整改措施包括加強生產(chǎn)過程控制、修訂內(nèi)控標準、加強原輔包質(zhì)量控制等。多管齊下的整改措施有效促進了藥品質(zhì)量的提升，取得了令人滿意的成果。同時，也存在風險排查失敗等情況，建議國家藥品抽檢承檢機構(gòu)進一步提升探索性研究的科學性和靶向性；建議生產(chǎn)企業(yè)正確認識該項工作，運用多種手段進行風險排查；建議藥監(jiān)部門加強對生產(chǎn)企業(yè)的督促、指導和幫扶，促進生產(chǎn)企業(yè)針對相關(guān)風險積極認真開展排查并切實整改到位，夯實藥品質(zhì)量安全的主體責任。

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