Module 4 - Safety

  • VICH Residue Guidelines (VICH GL46 to 49, 56 and 57) - Data Requirements for setting Withdrawal Periods (presentation from ASEAN Training on VICH, 26-27 April 2017, Brunei)

a) Brief Introduction for Approval System of Antimicrobials in Japan
b) VICH GL27: Guidance on Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food Producing Animals with Respect to Antimicrobial Resistance
c) VICH Residue Guidelines - Data Requirements for setting Withdrawal Periods (with reference to VICH GLs 46, 47, 48, 49, 56 and 57)
d) The application of GL27 in the authorisation of antimicrobials in the EU (November 2020)
e) AMR public health risk assessment for veterinary medicines in the EU - Application of VICH GL27 (November 2020)
f) Risk analysis of VMPs in Japan (October 2020) -
g) Assessing antimicrobial resistance risks: VICH GL27 & FDA Guidance for Industry (November 2020)
h) NEW Marker Residue Depletion studies to establish product withdrawal periods in aquatic species - GL57 (JMAFF, November 2020) - To be uploaded...