DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)11.2.2 STEP 2: NEW REGISTRATION APPLICATION FORMPlease click at „Section List‟ button to display the application form at Step 2. Therequirement displayed will depend on the category of product being selected forregistration submission:Abridged Evaluation for certain **OTCs, health supplements and naturalproducts;Generic Pharmaceutical Products - Parts I & II;Existing chemical or biological entity(s) in new dosage form - Parts I & IItogether with pharmacokinetic data;NDP and Biologics - Parts I to Part IV:- Part I - Administrative Data and Product Information- Part II - Quality(For details of Part II, please refer Section C: Quality Control inthe main DRGD)- Part III - Nonclinical Document- Part IV - Clinical Document.Please refer Glossary developed for the ACTD and ACTR. The definitions used inthe glossary have been developed for the ASEAN Common Technical Dossier(ACTD) and Common Technical Requirements (ACTR). They are not necessarilymeaningful outside the scope of the specific parts of ACTD and ACTR to which theyrefer.PART I – ADMINISTRATIVE DATA AND PRODUCT INFORMATIONSECTION A: PRODUCT PARTICULARSDetails of the following as entered under Step 1 will appear automatically in theapplication form:1. Product name;2. Name and Strength of Active IngredientsName and Strength of Excipients; and3. Dosage form.Other fields as follow, shall be completed:4. Product Description:State, briefly on visual and physical characteristics of the product,including (where applicable):Shape, size, superficial markings for identification purposes, colour, odour,taste, consistency, type of tablet coating, type of capsule, etc.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 440