DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)8.1 PRE-SUBMISSION OF APPLICATIONPrior to submission of an application for product registration, applicant shall determine/understand:a) The category of the product (different product category requires different data);b) Method of evaluation;c) General and specific requirements;d) Conditions applied;e) Multiple applications;f) Variants; andg) Language.A product shall only be registered if it fulfills regulatory requirements imposed by theAuthority, especially with respect to quality, efficacy and safety of the product andtaking into consideration on the following criteria:a) Necessity of the product;b) Potential for abuse; andc) Therapeutic advantages.8.1.1 CATEGORY OF PRODUCTApplicant shall determine on the category of a product, as described under Section A -General Overview.If the product category is uncertain, applicant may submit a Classification Form to Sectionof Regulatory Coordination, Centre for Product Registration, NPCB for verification.8.1.2 METHOD OF EVALUATIONMethod of evaluation for registration of a product is divided into two (2) types, which are:a) Full Evaluation; andb) Abridged Evaluation.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 71