Module 3 Presentations

07/05/2024

Contact Points

INN Dr R Balocco Mattavelli World Health Organization 1211 Geneva 27 Switzerland email: innprogramme@who.int BAN/INN British Pharmacopoeia Commission 151 Buckingham Palace Road London SW1W 9SZ UK email: bpcom@mhra.gov.uk Tel: +00 44 (0) 20 3080 6561

USAN The USAN Program American Medical Association 515 North State Street, Chicago,IL 60610 USA email: USAN@ama-assn.org Tel: 00 1 312 464 4045

Nomenclature and Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

35

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 Characterisation of the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

36