DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)1.2 CATEGORIES OF PRODUCTNote:Before submission of application for a product registration, applicants mayverify via Classification Form if unsure for the product category.Medicinal products for registration are classified under the following categories:1.2.1 NEW DRUG PRODUCTSNew Drug Products (NDP) is defined as any pharmaceutical products that havenot been previously registered in accordance with the provisions of the CDCR1984.An NDP may be classified according to the following categories:a) New Chemical Entity (NCE)/ Radiopharmaceutical SubstanceA new pharmaceutical product containing any of the following:i. New Chemical Entity (NCE)Defined as an active moiety that has not been registered in anypharmaceutical product.ii. Radiopharmaceutical substanceDefined as a radionucleotide, ligand or the coupling mechanism tolink the molecule and the radionucleotide that has not beenregistered in any pharmaceutical product.b) New Combination ProductA new pharmaceutical product containing two or more drugs that arephysically, chemically or otherwise combined or mixed and producedNational Pharmaceutical Control BureauFirst Edition, January 201332