[201207中国-欧盟药品质量相关法规研讨资料]药典的协调.pdfVIP

Pharmacopoeial harmonisation… an industry perspective Dr Stephen W. Cook EC-China High Level Regulatory Dialogue Workshop on GMP/Pharmacopoeia/APIs th 11-12 July 2012 药典的协调… 工业界展望 中国-欧盟药品注册高层对话 GMP/药典/APIs研讨会 th 11-12 July 2012 / 2012年7月11 - 12 日 144 Introduction • Harmonised pharmacopoeia help to ensure patient access to high quality medicines and vaccines worldwide • As part of the 2015 ChP development, Industry recognises; – Increased opportunity to provide comments for 2015 ChP revisions – Greater clarity on the drafting procedures – Engagement by CPC with other pharmacopoeial bodies – Reference to other pharmacopoeias during drafting of monographs • Industry encourages this development and would like to raise several points for discussion Introduction 引言 • 协调药典有助于保证患者使用世界上的高质量药品和疫苗。 • 作为2015版中国药典发展的一部分，企业认识到： – 提供2015版中国药典修订说明的机会增加； – 起草规程更清晰； – CPC与其它药典机构的参与； – 专论起草过程中参考其它药典。 • 行业支持这样发展，希望提出几点供讨论。 145 Points of Discussion 1. Pharmacopoeial harmonisation 2. The level of detail in the monographs 3. Expert committees and industry involvement 4. Consideration for product development 5. Documented process for review Points of Discussion 讨论要点 1.药典的协调 2.专论的详细程度 3.专家委员会和企业参与 4.产品开发的考虑因素 5.书面审查流程 146 1. Pharmacopoeial harmonisation So