Veterinary Products Management and Quality Control System in

Veterinary Products Management and Quality Control System in Thailand : Veterinary Vaccine Tasanee Lorchaivej Workshop on the Veterinary Products for Asian Countries 2010 22 - 26 November 2010 The National Veterinary Research and Quarantine Service

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. 2510 (A. D. 1967) and its amendments 2

The current laws The Drug Act B. E. 2510 (A. D. 1967) amended by Drug Act (No. 2) B. E. 2518 (A. D. 1975) Drug Act (No. 3) B. E. 2522 (A. D. 1979) Drug Act (No. 4) B. E. 2527 (A. D. 1984) Drug Act (No. 5) B. E. 2530 (A. D. 1987) 3

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

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 5

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 6

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 7

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 8

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 9

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 10

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

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 Approved Credential certificate of drug registration More information / Revision Reject 12

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 13

MA Procedure for Vaccine 1 Mfg / Import License 2 Mfg. / Import drug sample 3 Registration 4 Lot release Market / Use 14

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 15

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

Number of Manufacturer/Importer 17

POPULATION / PRODUCTION (Million) 0 73. 6 8 1040 18

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Market size 2009 (Baht / Year) 20

Market size 2010 (Baht / Year) 21

THANK YOU FOR YOUR ATTENTION 22