Regulation for Aquaculture Medicines in Japan Mototaka Hiki

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Regulation for Aquaculture Medicines in Japan Mototaka Hiki. , D. V. M. Fish and

Regulation for Aquaculture Medicines in Japan Mototaka Hiki. , D. V. M. Fish and Fishery Products Safety Office, Food Safety and Consumer Affairs Bureau, Ministry of Agriculture, Forestry and Fisheries (MAFF)

Today’s Topics 1. Aquaculture In Japan 2. Aquatic Drugs Focusing on Vaccines 3. Regulation for

Today’s Topics 1. Aquaculture In Japan 2. Aquatic Drugs Focusing on Vaccines 3. Regulation for Aquatic Drugs

Aquaculture Market (Million )

Aquaculture Market (Million )

Annual Aquaculture Production (2014) From Annual Statistics on Fishery Aqua culture Production (MAFF Order

Annual Aquaculture Production (2014) From Annual Statistics on Fishery Aqua culture Production (MAFF Order Perciformes account for 79 % of all aquaculture production in Japan

Annual Farming Production of Yellowtail and Flounder   Yellowtail Flounder From Annual Statistics on

Annual Farming Production of Yellowtail and Flounder   Yellowtail Flounder From Annual Statistics on Fishery and Aquaculture Production (MAFF)

Annual Farming Damage of Yellowtail and Flounder  Million  Yellowtail Flounder From National Statistics

Annual Farming Damage of Yellowtail and Flounder  Million Yellowtail Flounder From National Statistics (MAFF)

Three Major Diseases of Yellowtail and Flounder  Species Diseases\Years Yellowtail 1 st Diseases Damage

Three Major Diseases of Yellowtail and Flounder  Species Diseases\Years Yellowtail 1 st Diseases Damage ratio 2 nd Diseases Damage ratio 3 rd Diseases Damage ratio Flounder 1 st Diseases Damage ratio 2 nd Diseases Damage ratio 3 rd Diseases Damage ratio 1998 Lactococcosis* 2003 2009 Nocardiosis 53. 2% 28. 0% Iridovirus infection* Lactococcosis 11. 8% 20. 9% Photobacteriosis (Pseudotuberculosis)* 10. 9% Edwardsiellosis 39. 4% Streptococcosis* 23. 0% Sea Anemonea stings 9. 1% 30. 0% Lactococcosis 26. 9% S. dysgalactiae infection* Unknown diseases 18. 6% 9. 2% Edwardsiellosis 57. 5% 50. 8% Viral Nervous Necrosis (VNN) Streptococcosis (Not identified) 8. 9% Streptococcosis 7. 6% 28. 1% Viral hemorrhagic septisemia (VHS) 5. 5% * Approval years of vaccines; For Lactococcusis; 1997、Iridovirus ; 1998、Photobacteriosis: 2008、Streptococcus dysgalactiae : 2010、Streptococcosis (S. iniae ; Flounders) 2004.

Today’s Topics 1. Aquaculture In Japan 2. Aquatic Drugs Focusing on Vaccines 3. Regulation for

Today’s Topics 1. Aquaculture In Japan 2. Aquatic Drugs Focusing on Vaccines 3. Regulation for Aquatic Drugs

Drugs for Aquaculture Kinds of aquatic drugs(Oct.  2015) Aquatic Medicines Antimicrobials General products ・Active

Drugs for Aquaculture Kinds of aquatic drugs(Oct.  2015) Aquatic Medicines Antimicrobials General products ・Active element: ・ anthelmintic : 6 ・ antiseptic: 2 17 kinds ・ anesthetic : 1 ・ vitamin etc ※No. of active elements Aquatic Biologics Vaccines ・Killed Vaccine: 17 kinds 27 products

History of Fish Vaccines In Japan 1988   -Development of the first fish vaccine Immersion

History of Fish Vaccines In Japan 1988   -Development of the first fish vaccine Immersion vaccine against Vibriosis in Ayu and Rainbow Trout 1990’s  -Development of an oral vaccine for Lactococcus garviae in Yellowtail, and an injection vaccine against Iridovirus in Red sea bream 2000’s -Development of combined vaccines and oil adjuvant vaccines  

Fish Vaccines Type of Vaccine: Killed vaccine Administration method : Immersion / Orally /

Fish Vaccines Type of Vaccine: Killed vaccine Administration method : Immersion / Orally / By injection Immersion Orally By injection

Major Species of Fish that are Vaccinated Freshwater Fish Marine Fish yellowtail Red sea

Major Species of Fish that are Vaccinated Freshwater Fish Marine Fish yellowtail Red sea bream great amberjack Seriola fishes rainbow trout flounder grouper (From Fish Species reference Book, pub. Hokuryu-kan)

Target Classification of Drugs for Aquaculture Drugs for aquaculture have been approved as follows:

Target Classification of Drugs for Aquaculture Drugs for aquaculture have been approved as follows: Target fish Aquatic Medicines Antimicrobials ・Classification by order Vaccines General products Aquatic Biologics Vaccines ・Classification by Genus or species Vaccines for aquaculture have been approved according to genus or species. 13

A case report about the vaccine efficacy 100 milion 10 thousand Fish 10 thousand

A case report about the vaccine efficacy 100 milion 10 thousand Fish 10 thousand Year Estimated damage cost by Lactoccosis Amount use of antibiotics (macrolide) Number of fish vaccinated with Lactoccosis ※Oita PRFE Case in yellowtail From Oita prefecture reports

Large-scale vaccination of Amberjack ①Capture ③Injection ②Anesthesia ④Release Photo by Dr. Hirae (Kagoshima Pref.

Large-scale vaccination of Amberjack ①Capture ③Injection ②Anesthesia ④Release Photo by Dr. Hirae (Kagoshima Pref. )

Large-scale vaccination of Amberjack Injection machine Photo by Dr. Hirae (Kagoshima Pref. )

Large-scale vaccination of Amberjack Injection machine Photo by Dr. Hirae (Kagoshima Pref. )

Today’s Topics 1. Aquaculture In Japan 2. Aquatic Drugs Focusing on Vaccines 3. Regulation for

Today’s Topics 1. Aquaculture In Japan 2. Aquatic Drugs Focusing on Vaccines 3. Regulation for Aquatic Drugs

Regulation for Aquatic Drugs Prefectural governments Inspection Section of animal pharmaceutical affairs cooperation pharmaceutical inspector

Regulation for Aquatic Drugs Prefectural governments Inspection Section of animal pharmaceutical affairs cooperation pharmaceutical inspector Lecture Section of fisheries Fisheries Experimental Station Fishery Cooperatives and Federations of Distributor Fishery Cooperatives Inspection cooperation Lecture Section of food sanitation Aquaculture farmer 18 aquatic animals

Procedure for Using Aquatic Drugs Prefectural governments Section of animal pharmaceutical affairs Fishery Cooperatives

Procedure for Using Aquatic Drugs Prefectural governments Section of animal pharmaceutical affairs Fishery Cooperatives and Federations of cooperation Fishery Cooperatives ③ Section of fisheries Fisheries Experimental Station ② cooperation Distributor ① ① ④ ② ③Order drugs ④Sell drugs ⑤Use drugs Section of food sanitation Aquaculture farmer ①Consultation, ②Guidance Aquaculture 19 aquatic animals

Regulation for Use of Aquatic Vaccines Aquaculture farmer submits application form for permission of

Regulation for Use of Aquatic Vaccines Aquaculture farmer submits application form for permission of use aquatic vaccines before use 20

Certification for Use of Aquatic Vaccine ・Name of aquaculture farmer ・Number and Date of

Certification for Use of Aquatic Vaccine ・Name of aquaculture farmer ・Number and Date of issue ・Date of lecture for administration ・Target fish ・Target disease ・Treatment plan (date) ・Dosage , ・Information of issuing institution 21

Thank you for your attention Mototaka Hiki D. V. M Fish and Fishery Products

Thank you for your attention Mototaka Hiki D. V. M Fish and Fishery Products Safety Office, Food Safety and Consumer Affairs Bureau, Ministry of Agriculture, Forestry and Fisheries (MAFF) e-mail : [email protected] maff. go. jp