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Source: CDE website
The ICH Guiding Principles for Q2(R2): Validation of Analytical Methods and Q14: Development of Analytical Methods are now in Phase 3 Regional Public Comment Phase
.
The original English and Chinese translations of the draft guidelines Q2(R2) and Q14 are contained in annexes 1-4
.
If there are any relevant suggestions from all walks of life, please feedback
through the contact email address before July 15, 2022.
Contact: Tian Jie, Zeng Fanxu
Email: tianj@cde.
Appendix 1: Q2 (R2): Verification of analytical methods (draft)
Appendix 2: [Chinese] Q2 (R2): Verification of analytical methods (draft)
Appendix 3: Q14: Development of analytical methods (draft)
Appendix 4: [Chinese] Q14: Development of analytical methods (draft)
Appendix 5: [Template] Feedback on the English draft
Appendix 6: [Template] Chinese the feedback of the translation
Drug Evaluation Center of the State Drug Administration
April 25, 2022