Regulatory Authorities and Economic Blocs That Include the Subject “Degradation Products” in Their Guidelines
| Entity | Guidelines | Reference |
|---|---|---|
| WHO | Stability testing of active pharmaceutical ingredients and finished pharmaceutical products | (61) |
| ASEANb | ASEAN guidelines on stability studies of drug products | (62) |
| GCCc | The GCC Guidelines for Stability Testing of Drug Substances and Pharmaceutical Products | (63) |
| MCCd | Stability | (64) |
| FDAe TGAf Health Canada EMAg | Q3B (R2). Impurities in New Drug Products | (1) |
| Q3A (R2). Impurities in New Drug Substances | (65) | |
| Q1A (R2). Stability Testing of New Drug Substances and Products | (66) | |
| Q1B. Photostability Testing of New Drug Substances and Products | (67) | |
| Q1C. Stability Testing for New Dosage Forms | (68) | |
| Q1E. Evaluation of Stability Data | (69) | |
| ANVISAh | Resolution RE-01, July 29, 2005. Guideline on Stability Studies. | (70) |
aWHO, World Health Organization;
↵b ASEAN, Association of South East Asian Nations;
↵c GCC, Cooperation Council for The Arab States of the Gulf;
↵d MCC, Medicine Control Council;
↵e FDA, Food and Drug Administration;
↵f TGA, Therapeutic Goods Administration;
↵g EMA, European Medicines Agency;
↵h ANVISA, Brazilian Health Surveillance Agency.