DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)GenusSpeciesPart ofPlant/AnimalProhibited(whole plant/animalunlessotherwisespecified)Constituent ofConcern Reasonsfor ProhibitionReasons for Prohibition- Renal dysfunction andrelated to acute tubularnecrosis and glomerulardestructionMelaleuca alternifolia Tea tree oilSkin irritation, respiratorydistress, vomiting, diarrheaand cytotoxic for oraladministration.* Banned in oral preparation- Potential abusePapaverAll speciesMorphine andderivatives,codeine- Dependence, palpitation,hallucination, euphoricactivities, CNS depression- Nervous system toxicity- Possible death fromcirculatory and respiratoryfailurePilocarpuspinnatifoliusjaborandiBarkPilocarpineBronchospasm, ocularproblem, miosis, blurredvisionPodophyllumemodiipeltatumRoot, leafPodophyllin resin- Serious systemic toxicity withexcessive amounts(persistent nausea andvomiting, tachypnea, fever,stupor, coma, tachycardia,neuropathy and death)- Renal failure andhepatotoxicitySolanumdulcamaraLeaf,floweringtopsSolanaceousalkaloidsTypical antimuscarinic effecte.g. dry mouth, mydriasisNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 264
Drug Registration Guidance Document (<strong>DRGD</strong>)GenusSpeciesPart ofPlant/AnimalProhibited(whole plant/animalunlessotherwisespecified)Constituent ofConcern Reasonsfor ProhibitionReasons for ProhibitionStrophantusAll speciesStrophantusalkaloidsCardiac effect similar todigoxinSymphytumpregrinumPyrrolizidinealkaloidReported to cause livertoxicity2.1.4 USE OF PROTECTED/ ENDANGERED INGREDIENTSa) PROTECTED/ ENDANGERED WILDLIFE SPECIESIt is the responsibility of the applicant to ensure that the ingredient(s)derived from wildlife species its parts and derivatives used in theformulation COMPLIES with the Wildlife Conservation Act 2010 (Act716) and International Trade in Endangered Species Act 2008 (Act686). Both guidelines can be downloaded through this linkhttp://www.wildlife.gov.my.The applicant shall contact the following department to obtain thenecessary permit/ license. A copy of the permit/ license shall beattached together with the application form for product registration.Department of Wildlife and National Parks, Peninsular MalaysiaKm. 10, Jalan Cheras,56100 Kuala Lumpur,Tel: +603-90866800, Fax: +603-90753873b) ENDANGERED BOTANICAL SPECIESIt is the responsibility of the applicant to declare the source of thebotanical ingredient if it is listed under the International Trade inNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 265
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Page 230 and 231: PART III: NON-CLINICAL DATADrug Reg
Page 232 and 233: - All information must be provided
Page 242 and 243: 1.2 EXEMPTION FROM PRODUCT REGISTRA
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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