DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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PART IV: CLINICAL DOCUMENTSDrug Registration Guidance Document (DRGD)- Applicable to disease risk reduction claims (for new active ingredient, newcombination of active ingredients and new dose).Table 19:No. Field Disease Risk Reduction Claims1. Clinical overview √2. Production Development Rational √3.4.5.6.7.Overview of Bio-pharmaceutics- To include associated analytical methodsOverview of Clinical Pharmacology- Summary of clinical pharmacology studiesOverview of Efficiency- Summary of clinical efficacyOverview of Safety- Summary of clinical safetyReferences- List of all clinical studies- List of key literature references- Published clinical papers√√√√√National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 228
- All information must be provided in the following format/table:Drug Registration Guidance Document (DRGD)Forms ofstudySample sizeDurationRandomisationof groupsEndpointStatistical analysis ofdataRandomised,controlled,andpreferablyblindedinterventionstudiesMust bejustified andmust involvesufficientlylarge number ofsubjects toestimateincidence andnature ofpotentialadversereactionsMust bejustified andmust be ofsufficientduration toensure nosafetyconcernswith respectto long termuseAll groups shallhavecomparablebaselinevalues,particularly forthose factorsthat are knownto be, or maybe,confounders orrisk factorsAs adecreaseincidence ofthe diseaseor areduction ofa factor, or asurrogatethereof, ofthe manythatcontribute tothedevelopmentof a diseaseMethods to calculatethe sample size,setting the powerand the significancelevel at conventional80% and p
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Page 178 and 179: Drug Registration Guidance Document
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Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 230 and 231: ATTACHMENT 2Drug Registration Guida
Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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