Module 3 2019

References

➢ EMA/454576/2016 Guideline on the chemistry of active substances

➢ Chemistry of Active Substances. 3AQ5A

➢ Investigation of Chiral Active Substances. 3CC29A

➢ ICH Harmonised Tripartite Guideline Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances.CPMP/ICH/367/96

Nomenclature and Characterisationof the Active Ingredient

The Organisation for Professionals in Regulatory Affairs