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| Requirements in the revision of the safety content of marketed traditional Chinese medicine labeling |
| Hits 862 Download times 1057 Received:November 18, 2022 |
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| DOI
10.11656/j.issn.1672-1519.2023.01.13 |
| Key Words
traditional Chinese medicine;labeling;safety contents;revision |
| Author Name | Affiliation | E-mail | | AN Na | Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China | | | WANG Qingli | Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China | wangql@cde.org.cn | | ZHOU Bei | Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China | |
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| Abstract
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| Labeling is the basis to choose and use medicine for patients,to prescribe medicine for physician,and to dispense medicine for pharmacists. Labeling also plays an important role in guiding clinical medication. It is important to revise labeling in the pharmaceutical product lifecycle management. Combined with the drug review,this paper focuses on the technical requirements and common issues in the revision of the safety content of marketed traditional Chinese medicines labeling. Common issues include failure to prompt important safety risks,expansion of indications,insufficient supporting data,and irregular writing. Relevant content provides reference for marketing authorization holders to strengthen the safety research and evaluation of marketed traditional Chinese medicines,and to improve the safety content in labeling. |
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