Table II

Regulatory Authorities and Economic Blocs That Include the Subject “Degradation Products” in Their Guidelines

WHOStability testing of active pharmaceutical ingredients and finished pharmaceutical products(61)
ASEANbASEAN guidelines on stability studies of drug products(62)
GCCcThe GCC Guidelines for Stability Testing of Drug Substances and Pharmaceutical Products(63)
FDAe TGAf Health Canada EMAgQ3B (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)
ANVISAhResolution 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.