Regulation for Aquaculture Medicine 8 July 2015 Dr

  • Slides: 15
Download presentation
Regulation for Aquaculture Medicine 8 July 2015 Dr. Sasi Jaroenpioj Department of Livestock Medicine

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

Regulations under Drug Act Pre-marketing Control • Licensing • Registration • Adversetisment Control Post-marketing

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

List of licensed antimicrobials for use in aquatic animal in Thailand • • •

List of licensed antimicrobials for use in aquatic animal in Thailand • • • 2/25/2021 Amoxycillin Enrofloxcin Sarafloxacin Oxolinic acid Oxytetracycline Sulfadimethoxine sodium / Ormethoprim Sulfadimethoxine sodium / Trimethoprim Sulfadiazine and Trimethoprim Sulfadimidine and Trimetroprim Sulfamonomethoxine Sodium Toltrazuril

List of banned antimicrobials in aquatic animal in Thailand • Chloramphenical • Nitrofuran and

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 2/25/2021

Classification of Veterinary Drugs • Generic VMPs) Existing drugs( -For food producing animals -For

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

VMPs Registration Procedure 6

VMPs Registration Procedure 6

VMPs REGISTRATION PROCEDURE Apply for registration certificate Part I Safety and efficacy - Packaging

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

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

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

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

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

Document required for New Veterinary Drug for food producing spp. Submission (1) Chemical /

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

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

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

Document required for New Veterinary Drug for food producing spp. Submission (3) Toxicological Documents

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

Document required for New Veterinary Drug for food producing spp. Submission (4) Safety -

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

Document required for New Veterinary Drug for food producing spp. Submission (5) Clinical Documents

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

Thank you

Thank you

AQUACULTURE MARICULTURE AQUACULTURE The broad term aquaculture refersAQUACULTURE MARICULTURE AQUACULTURE The broad term aquaculture refers
AQUACULTURE MARICULTURE AQUACULTURE The broad term aquaculture refersAQUACULTURE MARICULTURE AQUACULTURE The broad term aquaculture refers
AQUACULTURE http www nmfs noaa govaquaculture AQUACULTURE AquacultureAQUACULTURE http www nmfs noaa govaquaculture AQUACULTURE Aquaculture
July 2015 July 2015 July 2015 July 2015July 2015 July 2015 July 2015 July 2015
Aquaculture expands global food supply Aquaculture background GrowingAquaculture expands global food supply Aquaculture background Growing
Aquaculture Aquaculture Objectives Explain How definitions are derivedAquaculture Aquaculture Objectives Explain How definitions are derived
Mariculture and Aquaculture Aquaculture is the application ofMariculture and Aquaculture Aquaculture is the application of
Bell Work Who developed Aquaculture Introduction to AquacultureBell Work Who developed Aquaculture Introduction to Aquaculture
Aquaculture Aquaculture the controlled production of animals thatAquaculture Aquaculture the controlled production of animals that
Aquaculture Fish farming Aquaculture The controlled production ofAquaculture Fish farming Aquaculture The controlled production of
Mariculture and Aquaculture Aquaculture is the application ofMariculture and Aquaculture Aquaculture is the application of
Aquaculture Animals Gina S Itchon Xavier university AquacultureAquaculture Animals Gina S Itchon Xavier university Aquaculture
Fish nutrition in aquaculture Fish nutrition in aquacultureFish nutrition in aquaculture Fish nutrition in aquaculture
Aquaculture in Lebanon Ibrahim AlHawi Anjar Aquaculture CenterAquaculture in Lebanon Ibrahim AlHawi Anjar Aquaculture Center