1. Veterinary Products Management and Quality Control System in Thailand : Veterinary Vaccine Tasanee Lorchaivej
Workshop on the Veterinary Products for Asian Countries November The National Veterinary Research and Quarantine Service

2. Introduction
 National Regulatory Authority  Food and Drug Administration (FDA) has roles and responsibilities to regulate health products in Thailand  Drug regulations including vaccine are regulated under Drug Act B.E (A.D. 1967) and its amendments

3. The current laws  The Drug Act B.E. 2510 (A.D. 1967) amended by
Drug Act (No. 2) B.E (A.D.1975)
Drug Act (No. 3) B.E (A.D.1979)
Drug Act (No. 4) B.E (A.D.1984)
Drug Act (No. 5) B.E (A.D.1987)

4. Organizational Chart FDA Drug Control Division Senior Experts
Drug Advisory
Committee / Sub committees
Drug Control Division
Senior Experts
New Drug
Generic Drug
Pharmacy Standard Project
Policy and System Development
IND & IA
Drug Industry & IPR
Veterinary Drug
Herbal and Traditional Drug
ED & SPC
Advertising Control
Biological Product
Post-Marketing Control

5. Regulation on Marketing Authorization of Vaccine
Marketing Authorization Approval of Vaccine is needed prior to importation or manufacture
Approval for Marketing Authorization should be based on assured quality, safety and efficacy accompanied by the CTD

6. Drug Registration System
Only the authorized licensee either manufacturer or
importer can apply for drug registration.
 There are 2 main steps :
1. Application for the permission to manufacture or import of drug sample for registration
2. Application for the approval of drug registration

7. Leaflet / insert Labels
Documents : Application for the permission to manufacture or import of drug sample for registration
Application form (Nor Yor 8, Por Yor 8)
Leaflet / insert
Labels

8. Documents : Application for Veterinary Vaccine Registration
Application form
Finished Product Specification and Control Method
Certificate of Free Sale (for Importation)
Labels
Leaflet / insert (Thai language), English (if any)
Approval for manufacture or import of drug sample for registration

9. Documents : Application for Veterinary Vaccine Registration (cont.)
Complete formula per unit dose
Master formula
Manufacturing process
Certificate of Analysis of finished product
Certificate of GMP
Certificate of Lot Release

10. Documents : Application for Veterinary Vaccine Registration (cont.)
Quality control
Raw material specification and control method
In-process control specification and control method
Finished product specification and control method
(incldg. shelf-life and storage condition)
Packaging and Labelling
Stability studies of finished product

11. Documents : Application for Veterinary Vaccine Registration (cont.)
Potency studies
Safety studies
Efficacy studies
Copy of license of manufacturer or importer
Others

12. Registration Procedure
І. Application for manufacture or import drug sample
Document review
Approved
ІІ. Application for drug registration
Document screening
Drug committee
Quality, Safety and Efficacy
More information / Revision
Reject
Approved
Credential certificate of
drug registration

13. Lot release Lot Release Certificate
- Vaccines are subject to apply for the “Certificate of Lot Release”
prior to the marketing after the approval of product license.
Review : meet or complied with the registration requirement
- Certificate of lot release issued by National Regulatory
Authority
- Summary Production Protocol

14. MA Procedure for Vaccine1 2 3 4
Mfg / Import
License
Lot release
Mfg. / Import
drug sample
Registration
Market / Use

15. Timeline and Fee  Registration - Timeline: 160 days
- Registration Fee: 2,000 Baht (~ 66,666 Won)
Lot Release Certification
- Timeline
* Certificate of lot release issued by National Regulatory Authority: 1 day
* Summary Production Protocol: 20 days
- Fee: Free

16. Number of approval Veterinary Vaccines (2008-2010)
Year
Local Manufacture
Importation
2007 - 58
2008 54
2009 61
2010
(October) 1
137

17. Number of Manufacturer/Importer

18. POPULATION / PRODUCTION (Million)
873.60
1040

20. Market size 2009 (Baht / Year)

21. Market size 2010 (Baht / Year)

22. THANK YOU
FOR YOUR ATTENTION