新西兰药品和医疗器械安全局对非处方类儿童感冒咳嗽药的评价与对策

Evaluation and Countermeasures on OTC Cough and Cold Medicines for Children in New Zealand

目的:介绍新西兰药品和医疗器械安全局应对非处方类儿童感冒咳嗽药安全性、有效性问题的策略,为我国进行药品风险-效益评价、提出合理管理措施提供借鉴。方法:从感冒咳嗽药的相关概念入手,介绍新西兰药品和医疗器械安全局对非处方类儿童感冒咳嗽药的评价及决策信息。结果与结论:新西兰药品和医疗器械安全局对非处方类儿童感冒咳嗽药的综合回顾与评价、阶段研究与决策、动态跟踪及客观求实的态度,对我国的药品上市后评价具有借鉴意义。

OBJECTIVE：To introduce positive response to the security and effectiveness issues on OTC cough and cold medicines for children in New Zealand in order to provide reference for drug risk-benefit evaluation and putting forward reasonable management measures in China. METHODS：The concept of OTC cough and cold medicines for children were introduced firstly. Then the evaluation and countermeasures of OTC cough and cold medicines for children in New Zealand were also introduced. RESULTS CONCLUSIONS：It has significance for the evaluation of drugs for sale that are review and evaluation,study and countermea-sures and dynamic tracking for OTC cough and cold medicines for children in New Zealand and the realistic attitude of New Zealand Drug and Medical Instruments Security Bureau.