Regulatory Requirements for Investigational Drugs - à¸à¸£à¸°à¸à¸£à¸§à¸à¸ªà¸²à¸à¸²à¸£à¸à¸ªà¸¸à¸

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Thailand Food & Drug Administration Outline of the presentation • Drug Regulation Framework • Law, Regulation and Guidelines • Pre-marketing control , Post-marketing control • Importation of IND and IND-like system
Scope of Regulatory Control for Vaccines R&D Candidate Selection Thailand Food & Drug Administration GLP Pre-Clinical Study EC&FDA NDA/BLA IND GCP&GLP Clinical studies Phase I,II,III Licensing (1) SIX CONTROL FUNCTIONS AEFI Surveillance (2) Vaccine Quality Lot release (3) PMS Importers/Hospitals/ Health centers Pilot Scale Production Scale up Production Manufacturing Plant Industrial Scale Production cGMP cGMP/GMP GMP R&D = Research & Development GLP = Good Laboratory Practice GCP = Good Clinical Practice GMP = Good Manufacturing Practice Clinical Trial authorization (6) cGMP = Current Good Manufacturing Practice IND = Investigational New Drug Application EC = Ethic Committee FDA = Food and Drug Administration GMP Inspection (5) Lab Testing (4) Cold chain monitoring NDA = New Drug Application BLA = Biologic License Application PMS = Post Marketing Surveillance
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Regulatory Requirements for Investigational Drugs - à¸à¸£à¸°à¸à¸£à¸§à¸à¸ªà¸²à¸à¸²à¸£à¸à¸ªà¸¸à¸

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Regulatory Requirements for Investigational Drugs - à¸à¸£à¸°à¸à¸£à¸§à¸à¸ªà¸²à¸à¸²à¸£à¸à¸ªà¸¸à¸