1. Regulation for Aquaculture Medicine Dr. Sasi Jaroenpioj Department of Livestock Medicine THAILAND 8 July 2015

2. Regulations under Drug Act Pre-marketing Control Licensing Registration Adversetisment Control Post-marketing Control Licensee’,Pharmacists’ and Drug store surveillance as mentioned in the Act GMP Audit Drug Surveillance ADR Monitoring Drug Reevaluation

3. List of licensed antimicrobials for use in aquatic animal in Thailand Amoxycillin Enrofloxcin Sarafloxacin Oxolinic acid Oxytetracycline Sulfadimethoxine sodium / Ormethoprim Sulfadimethoxine sodium / Trimethoprim Sulfadiazine and Trimethoprim Sulfadimidine and Trimetroprim Sulfamonomethoxine Sodium Toltrazuril 10/1/2016

4. List of banned antimicrobials in aquatic animal in Thailand Chloramphenical Nitrofuran and their Metabolites (Furazolidone, Furaltadone,Nitrofurazone and Nitrofurantoin) Malachite green and Leuco-malachite green 10/1/2016

5. 5 Classification of Veterinary Drugs Generic VMPs (Existing drugs) - For food producing animals - For companion animals New VMPs - For food producing animals - For companion animals

6. 6 VMPs Registration Procedure

7. 7 VMPs REGISTRATION PROCEDURE Part II Drug quality and analytical method - Quality control -Manufacturing process -Stability data Part I Safety and efficacy - Packaging Component - Certificate of Free Sales - Safety&Efficacy dossier - Samples Experts Apply for registration certificate

8. 8 GENERAL DRUG REGISTRATION PROCESS Revision Reject Document Approval Registration Granted - Add. Document- Reference Experts

9. 9 Document required for New VMPs for food producing spp.submission

10. 10 The same as Generic drugs Route of synthesis for NCE Chemical / Pharmaceutical Documents Document required for New Veterinary Drug for food producing spp. Submission (1)

11. 11 Pharmacological Documents Pharmacokinetics Pharmacodynamics Document required for New Veterinary Drug for food producing spp. Submission (2)

12. 12 Risk Assessment Ø hazard identification Ø dose response assessment Ø exposure assessment Ø risk characterization Systemic toxicity l Hepatotoxicity (Pk+Pd) l Renal toxicity (Pk+Pd) l Reproductive toxicity (Pk+Pd) l Teratogenic toxicity (Pk+Pd) l Neurotoxicity (Pk+Pd) Human food safety Target animal safety NOAEL(NOEL) ADI Toxicological Documents Document required for New Veterinary Drug for food producing spp. Submission (3)

13. 13 - Human Safety - Target Animal Safety - Environmental Safety - User Safety - The analytical method to determine the drug in edible tissue Safety Document required for New Veterinary Drug for food producing spp. Submission (4)

14. 14 · Effectiveness - a study in a target species - a study in laboratory animal - any field investigation and in vitro study Clinical Documents Document required for New Veterinary Drug for food producing spp. Submission (5)

15. Thank you