关于环境中人类制药残留物风险减轻监管措施的提案
Caroline T A Moermond1, Cecilia Berg2, Ulrika Bergstrom3
1Centre for Safety of Substances and Products, National Institute for Public Health and the Environment (RIVM), P.O. Box 1, 3720 BA, Bilthoven, the Netherlands.
Regulatory toxicology and pharmacology : RTP
|July 11, 2023
概括
我们建议为药品营销许可提供一个务实的风险减缓方案,以减少环境风险. 该计划根据估计和测量环境度量化措施,确保有效性而不会造成不必要的负担.
科学领域:
- 环境科学 环境科学
- 药理学 药理学 是一个学科.
- 监管事务 监管事务
背景情况:
- 环境中的药品 (PiE) 带来了需要透明评估和缓解的风险.
- 当前的监管框架可能无法充分解决药物的环境影响.
- 准确的环境风险评估对于有效的缓解策略至关重要.
研究的目的:
- 为人用药品提出一个务实和量身定制的风险减轻方案.
- 确保环境风险减轻不会给监管机构或行业带来过度负担.
- 将环境考虑纳入药品的营销许可程序.
主要方法:
- 开发基于环境风险估计 (模型与测量数据) 的分层风险减缓方法.
- 设计有效,比例且易于实施的风险减缓措施.
- 为制药产品提出个人和一般风险减轻策略.
- 强调需要将营销许可和环境立法联系起来.
主要成果:
- 一个拟议的方案根据环境风险数据的确定性来区分风险减轻.
- 这些措施旨在为患者,医疗保健专业人员,监管机构和行业提供实用性.
- 该计划允许针对特定产品量身定制的干预措施和更广泛的一般环境保护措施.
- 将营销许可与环境法规相结合被认为是有效风险管理的关键.
结论:
- 拟议的风险减轻方案为管理制药环境风险提供了一个平衡的方法.
- 有效的环境风险管理需要一个可适应和综合的监管框架.
- 实施该计划可以减少环境中的制药污染,而不会影响患者获取或医疗保健效率.
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