ICH系列分别都是哪一年生效的

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：

ICH Q1A(R2) Stability Testing of New Drug Substances and Products - 1993
ICH Q1B Photostability Testing of New Drug Substances and Products - 1996
ICH Q1C Stability Testing for New Dosage Forms - 1995
ICH Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products - 1999
ICH Q1E Evaluation of Stability Data - 2003
ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology - 2005
ICH Q3A(R2) Impurities in New Drug Substances - 2006
ICH Q3B(R2) Impurities in New Drug Products - 2006
ICH Q3C(R6) Impurities: Guideline for Residual Solvents - 2017
ICH Q3D(R1) Elemental Impurities - 2019
ICH Q4B(R1) Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions - 2005
ICH Q5A(R1) Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin - 1999
ICH Q5B Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products - 1996
ICH Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products - 1996
ICH Q6A(R2) Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances - 2008
ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products - 1999
ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients - 2000
ICH Q8(R2) Pharmaceutical Development - 2009
ICH Q9 Quality Risk Management - 2005
ICH Q10 Pharmaceutical Quality System - 2008
ICH Q11 Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) - 2012
ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management - 2019

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