国家药品抽检中补充检验方法的建立情况分析

假冒伪劣药品危害公众健康,打击药品掺杂掺假是世界各国药品监管机构的普遍共识。补充检验方法作为药品质量标准的补充,用于甄别药品中可能存在的掺杂掺假情况,对净化药品市场发挥重要的作用。中国十分重视通过补充检验方法打击药品掺杂掺假行为,法律法规健全,并出台了相关指南。通过分析补充检验方法相关政策法规和国家药品抽检建立补充检验方法的要求、优势和基本流程,以及2013年来获批的情况,可以发现国家药品抽检工作对补充检验方法的建立具有多方优势,取得了丰硕的成果。建议国家药品抽检工作中发挥优势加强补充检验方法的建立,利用探索性研究手段开展已批补充检验方法再评价,将“绿色化学”理念运用于补充检验方法建立工作中。

Analysis of establishment of supplementary testing methods in national drug sampling and testing

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.