Registration requirements for vaccines -Strategies

Transcript:Registration requirements for vaccines -Strategies:
Registration requirements for vaccines -Strategies to implement VICH GLs- Takashi KOZASA, DVM National Veterinary Assay Laboratory, Ministry of Agriculture, Forestry and Fisheries, Tokyo, Japan Presented at 8th VICH Outreach Forum @Buenos Aires, March 1, 2017 Vaccines -OIE Terrestrial Manual (2015)- [Chapter 1.1.8.] Principles of veterinary vaccine production A reliable supply of pure, safe, potent, and effective vaccines is essential for maintenance of animal health and the successful operation of animal health programmes. Immunisation of animals with high quality vaccines is the primary means of control for many animal diseases. In other cases, vaccines are used in conjunction with national disease control or eradication programmes. 3 VICH guidelines and dossier requirements for veterinary vaccines in Japan The Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics A person intending to market a drug*2 , a quasi-drug*3, a cosmetic containing the ingredients designated by the Minister or a medical device*4 shall, for each product, obtain marketing approval of the Minister with respect to its marketing. 4 *1 This English text of law is the previous text before revision. *2 Excluding drugs with the standards specified and designated by the Minister and in vitro diagnostic reagents specified under Article 23-2, Paragraph 1 *3 Excluding those with the standards established by the Minister *4 Excluding general medical devices and controlled medical devices designated by the Minister pursuant to the provisions of the same paragraph Article 14*1 Application for Marketing Approval Name and address of manufacturer License No. of manufacturer Type of license Name of drug Ingredients and quantities Manufacturing method Administration and dosage Label claim Condition for storage Shelf life Quality control testing and acceptance criterion References App.1: Origin and background of the discovery App.2: Physicochemical properties App.3: Production protocol App.5: Stability App.9: Target Animal Safety App.10: Efficacy App.14: Clinical trial 5 Composition of dossiers (application form with background study data) Appendix 1 The origin and background of the development Purpose of development Information on the target disease(s) Information on outbreaks of the target disease(s) in Japan Information on the similar products approved in foreign countries Component comparison with similar vaccines already approved in Japan 6 Appendix 2 Physicochemical property of vaccine strain Origin of the strain and seed production process Attenuation, strain marker and stability (live vaccine) Excretion and cohabitation infection (live vaccine) Immunogenicity Absence of reversion to virulent form (VICH