Module 4 - Safety

A. Antimicrobial resistance

a) VICH GL27 and registration of antimicrobials (VOF 13, November 2020)

• The application of GL27 in the authorisation of antimicrobials in the EU (November 2020)
• AMR public health risk assessment for veterinary medicines in the EU – Application of VICH GL27 (November 2020)
• Assessing antimicrobial resistance risks: VICH GL27 & FDA Guidance for Industry (November 2020)
• Risk analysis of VMPs in Japan, with focus on antimicrobials (October 2020) – https://youtu.be/zjanOTa3Smo

b) VICH GL27 and registration of antimicrobials (ASEAN Training on VICH, 26-27 April 2017, Brunei)

• VICH GL27: Guidance on Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food Producing Animals with Respect to Antimicrobial Resistance (April 2017)
• Brief Introduction for Approval System of Antimicrobials in Japan (April 2017)

B. Residues and consumer safety

• VICH Residue Guidelines – Data Requirements for setting Withdrawal Periods (with reference to VICH GLs 46, 47, 48, 49, 56 and 57) (VOF 12, February 2019)
• Marker Residue Depletion studies to establish product withdrawal periods in aquatic species – GL57 (JMAFF, November 2020) – https://www.youtube.com/playlist?list=PLw6_zS5yL7A65t3n1Y-8jPY-W0u7djh-O

C. Environmental Safety Assessment

• The VICH guidelines on Environmental Risk Assessment of Veterinary Medicines – VICH GL6 and GL38 (VOF 14, November 2021)
• The implementation of VICH GL6 and GL38 in Evaluating the Environmental Impact of Animal Drugs

a. in the EU
b. in the USA
c. in Japan https://youtu.be/mlpHlT05DiE 

• NEW  Follow up Questions and Answers arising from the training presentations (February 2022)