DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)70. GLUCOSAMINE70.1 The following statement shall be included on the labels and packageinserts of products containing Glucosamine (derived from seafood);“DERIVED FROM SEAFOOD”70.2 The following statement shall be included in the package inserts ofproducts containing Glucosamine:SIDE EFFECTCardiovascularPeripheral oedema, tachycardia were reported in a few patientsfollowing larger clinical trials investigating oral administration inosteoarthritis. Causal relationship has not been established.Central nervous systemDrowsiness, headache, insomnia have been observed rarely duringtherapy (less than 1%).GastrointestinalNausea, vomiting, diarrhoea, dyspepsia or epigastric pain,constipation, heartburn and anorexia have been described rarelyduring oral therapy with glucosamine.SkinSkin reactions such as erythema and pruritus have been reportedwith therapeutic administration of glucosamine.Reference:a) Circular Bil (52) dlm BPFK/02/5/1.3: Muatkan Kenyataan 'Derived From Seafood'Pada Label Produk Jika Bahan AKtif Adalah Dari Sumber Laut'b) Circular Bil (72) dlm BPFK/02/5/1.3: Mengemaskini dan menyelaraskan maklumatmengenai kesan sampingan pada label & sisip bungkusan produk yang mengandungiglucosamine71. HIV PROTEASE INHIBITORSThe following statement shall be included in the package inserts of productscontaining HIV Protease inhibitors:ADVERSE REACTIONAlthough a causal relationship has not been definitively established, proteaseinhibitors may contribute to increase in blood sugar levels and even diabetesin HIV patients. Close monitoring of blood glucose level is recommended.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 386
Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)72. HYDROQUINONEThe following warning shall be included on the outer labels of productscontaining Hydroquinone:WARNING:Some users of this product may experience skin irritations. Should this occur,stop using and consult a medical doctor.For hydroquinone products that do not contain any sun screening agent, astatement should be included in the package insert to advise users to eitheruse a sun screening agent or protect themselves from sunlight or to use theproducts only at night.Reference: Circular (bil 26) dlm bpfkweb.bpkp.3.2000: Amaran bagi Produk MengandungiHydroquinone73. IMMUNOSUPPRESANTSThe following information shall be included in the package inserts of productscontaining the following immunosuppressants:a) Sirolimusb) Cyclosporinc) Mycophenolate mofetild) Mycophenolic acide) TacrolimusWARNINGS AND PRECAUTIONSImmunosuppressed patients are at increased risk for opportunistic infections,including activation of latent viral infections. These include BK virus associatednephropathy which has been observed in patients receivingimmunosuppressants. These infections may lead to serious, including fataloutcomes.Reference: Circular Bil (44) dlm. BPFK/PPP/01/03: Kenyataan Amaran Berkaitan Dengan“Increased Risk For Opportunistic Infections Such As Activation of Latent Viral InfectionsIncluding BK Virus – Associated Nephropathy” Yang Perlu Dimuatkan Pada Sisip BungkusanProduk Immunosuppressant74. INSULINThe label of the product shall state clearly the source of insulin.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 387
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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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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