ICH系列指南和规范生效年份：详细清单

ICH系列是指国际药品注册协调委员会（International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use）制定的一系列药品质量和安全的指南和规范。以下是ICH系列各指南和规范的生效年份：\n\n1. ICH Q1A(R2) Stability Testing of New Drug Substances and Products - 1993\n2. ICH Q1B Photostability Testing of New Drug Substances and Products - 1996\n3. ICH Q1C Stability Testing for New Dosage Forms - 1995\n4. ICH Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products - 1999\n5. ICH Q1E Evaluation of Stability Data - 2003\n6. ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology - 2005\n7. ICH Q3A(R2) Impurities in New Drug Substances - 2006\n8. ICH Q3B(R2) Impurities in New Drug Products - 2006\n9. ICH Q3C(R6) Impurities: Guideline for Residual Solvents - 2017\n10. ICH Q3D(R1) Elemental Impurities - 2019\n11. ICH Q4B(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - 2005\n12. ICH Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin - 1999\n13. ICH Q5B Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products - 1996\n14. ICH Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products - 1996\n15. ICH Q6A(R2) Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances - 2008\n16. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products - 1999\n17. ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients - 2000\n18. ICH Q8(R2) Pharmaceutical Development - 2009\n19. ICH Q9 Quality Risk Management - 2005\n20. ICH Q10 Pharmaceutical Quality System - 2008\n21. ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) - 2012\n22. ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management - 2019\n\n以上是ICH系列指南和规范的生效年份的一些例子，还有其他相关指南和规范的生效年份可以在ICH官方网站上找到详细信息。