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

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)

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

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

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

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

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

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

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

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

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

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

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

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

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

Number of Manufacturer/Importer

POPULATION / PRODUCTION (Million) 873.60 1040

Market size 2009 (Baht / Year)

Market size 2010 (Baht / Year)

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