DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)2.2 APPLICABILITY AND DATE OF COMING INTO FORCEThe directive is applicable to:i) New drug product containing a new chemical entity; andii) Second indication of a registered drug product.New drug product containing any new chemical entity means a product that containsan 1 active moiety that has not been registered in accordance with the provisions ofthe CDCR 1984.1 An active moiety is defined as the molecule or ion, excluding those appendedportions of the molecule that cause the drug to be an ester, salt (including a salt withhydrogen or coordination bonds) or other non-covalent derivative (such as acomplex, chelate or clathrate) of the molecule, responsible for the physiological orpharmacological action of the drug substance.Second indication for a registered drug product means a single or cluster oftherapeutic indications applied subsequent to the first indication(s) approved at thepoint of registration of the product. The application for approval of the secondindication contains reports of new clinical investigations other than bioavailabilitystudies.The directive shall come into force on 1 st March 2011.2.3 GRANT OF DATA EXCLUSIVITYAny person may apply for Data Exclusivity. Such application shall be made uponsubmission of documents to the Director of Pharmaceutical Services for the:a) Registration of a new drug product containing a new chemical entity; orb) Approval for second indication of a registered drug product.An application for Data Exclusivity shall only be considered if the application inMalaysia for:a) New drug product containing a new chemical entity is made within eighteen (18)months from the date the product is first registered or granted marketingauthorization; ANDNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 51