假冒偽劣藥品危害公眾健康，打擊藥品摻雜摻假是世界各國藥品監(jiān)管機(jī)構(gòu)的普遍共識。補(bǔ)充檢驗(yàn)方法作為藥品質(zhì)量標(biāo)準(zhǔn)的補(bǔ)充，用于甄別藥品中可能存在的摻雜摻假情況，對凈化藥品市場發(fā)揮重要的作用。中國十分重視通過補(bǔ)充檢驗(yàn)方法打擊藥品摻雜摻假行為，法律法規(guī)健全，并出臺了相關(guān)指南。通過分析補(bǔ)充檢驗(yàn)方法相關(guān)政策法規(guī)和國家藥品抽檢建立補(bǔ)充檢驗(yàn)方法的要求、優(yōu)勢和基本流程，以及2013年來獲批的情況，可以發(fā)現(xiàn)國家藥品抽檢工作對補(bǔ)充檢驗(yàn)方法的建立具有多方優(yōu)勢，取得了豐碩的成果。建議國家藥品抽檢工作中發(fā)揮優(yōu)勢加強(qiáng)補(bǔ)充檢驗(yàn)方法的建立，利用探索性研究手段開展已批補(bǔ)充檢驗(yàn)方法再評價，將“綠色化學(xué)”理念運(yùn)用于補(bǔ)充檢驗(yàn)方法建立工作中。

Counterfeit and inferior drugs endanger public health, and combating drug adulteration is the general consensus of drug regulatory agencies around the world. As a supplement to drug specifications, supplementary testing methods are used to identify possible adulteration in drugs and play an important role in purifying the drug market. China attaches great importance to the use of supplementary test methods to combat counterfeit drugs, with sound laws and regulations, and has issued establishment guidelines. By analyzing the relevant policies and regulations, requirements, procedures, advantages as well as the approval situation since 2013, we can find that the national drug sampling and testing has many advantages in the establishment of supplementary test methods, and fruitful results have been achieved since 2013. It is recommended to strengthen supplementary test methods establishment, carry out re-evaluation of approved methods, and apply the concept of "green chemistry" by the exploratory research during the future national drug sampling and testing.

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