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Question: The adverse reactions in the instructions for traditional Chinese medicine after its launch are not yet clear, and no individual cases have been collected through all channels. What is the basis for modifying the content of adverse reactions in the instructions?
Answer: According to Article 75 of the Special Provisions on the Administration of Traditional Chinese Medicine Registration, holders shall strengthen the management of the entire life cycle of drugs, strengthen the monitoring, evaluation, and analysis of safety risks, and timely improve the [contraindications], [adverse reactions], and [precautions] of the Chinese medicine instructions in accordance with relevant technical guidelines. When collecting individual adverse reaction reports, attention should be paid to ensuring the effectiveness of various collection methods. For example, measures should be taken to ensure the uninterrupted service of hotlines used to collect safety information, literature search should ensure compliance with the search scope, agreements signed with distributors should include agreements on drug vigilance related activities, and internal training within the company should ensure comprehensive and effective measures. In response to the above issues, it is necessary to first clarify whether all collection channels are unobstructed. Secondly, traditional Chinese medicine has its own unique characteristics, and it is necessary to clarify the composition of the product, whether to collect safety information for each composition, whether to consider adverse reaction information in similar product manuals both domestically and internationally, and then comprehensively consider how to modify the adverse reaction section of this product manual.