WHO PQT/MED 发布 WHOPAR 口服剂型外观平实语言描述指南第二版更新
Updated guidance on plain language descriptions of visual appearance for oral dosage forms in WHOPARs
WHO 预认证团队药品组（PQT/MED）发布 WHOPAR 口服剂型外观视觉描述指南更新版，即第二版，适用于 WHOPAR 第 3 部分第 6 节和第 4 部分第 3 节。新版增加多层片描述建议，以及压印或印刷标记相对刻痕线位置的描述建议。PQT/MED 欢迎就该文件反馈，反馈可发送至 Mr Wondiyfraw Worku（[email protected]）。
News
21 September, 2026 - 00:12 (CEST)
Announcement
WHO Prequalification Team - Medicines (PQT/MED) has issued an updated version of its guidance on the recommended style to be used for visual description of oral dosage forms in WHOPARs. The guidance offers detailed advice on the description of the product to be used in WHOPAR Part 3 (Section 6) and WHOPAR Part 4 (Section 3), in order to ensure consistency and improve readability for the intended audiences.
Updated guidance on plain language descriptions of visual appearance for oral dosage forms in WHOPARs
This updated second version now also provides recommendations on how to describe multi-layer tablets and advice on describing the position of stamped or printed marks relative to a break line.
The guidance continues our ongoing commitment to ensure that all parts of the WHOPAR are as clearly written as possible, and to apply principles of readability shared with other stringent regulators. By updating it, PQT/MED aims to further support applicants for prequalification and improve transparency. We therefore welcome feedback on the document, which can be sent to Mr Wondiyfraw Worku ([email protected] )
来源：WHO 药品预认证与检查动态 · extranet.who.int