DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)CONTENTSGUIDELINE HISTORY……………………………………………………………………… 2PREAMBLE………………………………………………………………………………….. 4ABBREVIATIONS & ACRONYMS………………………………………………………... 6GLOSSARY…………………………………………………………………………………..12SECTION A: GENERAL OVERVIEW1. INTRODUCTION ............................................................................................. 251.1 REGISTRATION OF PRODUCTS ................................................................... 271.1.1 REGISTRABLE PRODUCTS .................................................................... 281.1.2 NON-REGISTRABLE PRODUCTS ........................................................... 281.1.3 EXEMPTIONS FOR PRODUCTS USED IN CLINICAL TRIALS ANDMANUFACTURING SAMPLES FOR REGISTRATION ............................. 311.2 CATEGORIES OF PRODUCT ......................................................................... 321.2.1 NEW DRUG PRODUCTS .......................................................................... 321.2.2 BIOLOGICS ............................................................................................... 341.2.3 GENERICS ................................................................................................ 351.2.4 HEALTH SUPPLEMENTS ......................................................................... 361.2.5 NATURAL PRODUCTS ............................................................................. 361.3 FOOD - DRUG - INTERFACE PRODUCTS .................................................... 381.3.1 INTRODUCTION ....................................................................................... 381.3.2 CLASSIFICATION OF FDI PRODUCTS ................................................... 391.3.3 PICTORIAL GUIDE TO CLASSIFICATION OF FOOD-DRUG INTERFACEPRODUCTS .............................................................................................. 421.3.4 ADDITIONAL GUIDANCE NOTES FOR FOOD PRODUCTS ..................... 441.4 MEDICAL DEVICE - DRUG - COSMETIC INTERFACE PRODUCTS............. 461.4.1 INTRODUCTION ....................................................................................... 46National Pharmaceutical Control BureauFirst Edition, January 201317