Global Regulatory Requirements Material (Pharmaceutics Sem 2 )

Validation of Pharmaceutical Processes, Equipments/Apparatus

Basics in drug approval process with ref. to

IND, NDA, ANDA, CONCEPT OF PARA I TO IV, EXCLUSIVITY

U.S. Food and Drug Administration

INTRODUCTION HISTORY STRUCTURE OF MCC STRUCTURE OF MRA

ANVISA

COMMON TECHNICAL DOCUMENT (CTD) & EUROPEAN MEDICINES AGENCY (EMEA)

MHRA

Therapeutic Goods Administration

ICH, WHO AND SUPAC GUIDELINES