基于2021年國(guó)家藥品抽檢探索性研究結(jié)果，針對(duì)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(fēng)險(xiǎn)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(guó)藥品監(jiān)管的創(chuàng)新性策略。2021年的問題排查有效率達(dá)80.80%，整改和預(yù)防率高達(dá)96.2%，生產(chǎn)企業(yè)采取召回措施的風(fēng)險(xiǎn)控制率為9.2%；暫停相關(guān)品種的生產(chǎn)或銷售的風(fēng)險(xiǎn)控制率為13.2%，整改措施包括加強(qiáng)生產(chǎn)過程控制、修訂內(nèi)控標(biāo)準(zhǔn)、加強(qiáng)原輔包質(zhì)量控制等。多管齊下的整改措施有效促進(jìn)了藥品質(zhì)量的提升，取得了令人滿意的成果。同時(shí)，也存在風(fēng)險(xiǎn)排查失敗等情況，建議國(guó)家藥品抽檢承檢機(jī)構(gòu)進(jìn)一步提升探索性研究的科學(xué)性和靶向性；建議生產(chǎn)企業(yè)正確認(rèn)識(shí)該項(xiàng)工作，運(yùn)用多種手段進(jìn)行風(fēng)險(xiǎn)排查；建議藥監(jiān)部門加強(qiáng)對(duì)生產(chǎn)企業(yè)的督促、指導(dǎo)和幫扶，促進(jìn)生產(chǎn)企業(yè)針對(duì)相關(guān)風(fēng)險(xiǎn)積極認(rèn)真開展排查并切實(shí)整改到位，夯實(shí)藥品質(zhì)量安全的主體責(zé)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