南非发展共同体 (SADC) 国家的药品外包装标签:对协调要求和过渡条款的比较分析
K Narsai1,2, F B Masekela3, H G M Leufkens1
1Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, The Netherlands.
大多数南非发展共同体 (SADC) 国家需要进行法律改革,以使药品包装标签与SADC协调指南保持一致. 这对区域和大陆的药物监管至关重要,包括非洲药物管理局 (AMA).
科学领域:
- 制药法规 制药法规 制药法规
- 药品协调 药品协调 药品协调 药品协调 药品协调
- 非洲区域一体化 非洲区域一体化
背景情况:
- 随着COVID-19的爆发,人们越来越需要在非洲协调医疗法规.
- 共同的技术标准,如药品外包装标签,对于有效的区域药品监管至关重要.
- 南非发展共同体 (SADC) 地区需要统一的标签要求.
研究的目的:
- 为了比较SADC国家对外包装标签的要求.
- 评估SADC地区药品标签协调的过渡条件.
- 评估SADC国家是否已准备好采用统一的标签准则.
主要方法:
- 到2023年2月,关于药品外包装标签立法的数据从16个国家药品监管机构 (NMRA) 收集到.
- 进行了比较性内容分析,以评估与SADC协调标签指南的一致性.
- 每个国家都评估了向SADC协调标签过渡的准备情况.
主要成果:
- 内容分析显示,至少有16个南美经合组织国家中的11个需要进行国家法律改革,以采用南美经合组织协调标签指南.
- 在所有分析国家的国家药物立法中,规定了外包装标签要求.
- 在国家标签要求中存在很高的调整水平,但需要进行立法更新.
结论:
- 尽管国家标签规则已经协调一致,但大多数南非亚洲国家需要立法改革才能采用统一的标签.
- 过渡到SADC统一的标签是朝着非洲药物管理局 (AMA) 的大陆统一迈出的必要一步.
- 立法协调对于在非洲推进区域和大陆药品监管至关重要.
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