DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)f) Traditional products are prohibited from containing ingredients derived fromhuman origin. For examples:i) CRINIS CARBONISATUS = Carbonised human hair(Reference: Pharmacopoeia Of The People‟s Republic Of China: EnglishEdition 1992)ii) HUMAN PLACENTA1.4 CLASSIFICATION FOR SPECIFIC ACTIVE INGREDIENTS1.4.1 PRODUCTS CONTAINING CASSIA/ SENNA:Products containing less than 0.5g of the crude drug or 20 mg sennoside(standardized preparation) are allowed make claims for general health only.(Reference: Micromedex)1.4.3 PRODUCTS CONTAINING PSYLLIUM HUSK/ PLANTAGO OVATAFinished products containing less than 3.5g of this active ingredient in asingle formulation and not in a pharmaceutical dosage form with specificdosage instructions will be classified as a non-drug. However quantitiesabove this amount and up to 6.9 g will require this product to be classified asa traditional product and will require registration before it can be marketed.(Reference: Circular on 14 May 2010 - Bil (24) dlm.BPFK/PPP/07/11Jld 5)2. GENERAL REQUIREMENTS FOR REGISTRATION OF NATURALPRODUCTS2.1 INGREDIENTS2.1.1 ACTIVE INGREDIENTSa) Active ingredients are those substances that have a therapeutic role in theformulation. Substances that are included in the formulation as activeingredients must make a contribution to the proposed indications for theproduct. Where a claim links the presence of an ingredient to the productNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 240
Drug Registration Guidance Document (DRGD)indication, that ingredient must contribute to that indication. The evidencemay be scientific and or traditional.b) Overages of active ingredientOverages may be used during manufacture. An overage is where the amountof an ingredient added during manufacturing that is greater than thenominated on the product label. Details of the overage used must beavailablec) Listed active ingredients can be checked through http://www.bpfk.gov.my ofproduct search. Ingredients not listed will require safety and/or efficacy dataevaluation prior to addition to this list.d) For new active ingredients or new combination products, the followinginformation shall be required:‣ Product containing new single ingredient:i) Extract form- Information on the taxonomy of the ingredient;- Techniques and methods in preparing/ processing the extract andsubsequently the product;- Information on the use and safety of the ingredient and the productQuality standard.ii) Powder/ Granules- Information on the taxonomy of the ingredient;- Techniques and methods in preparing/ processing the extract andsubsequently the product;- Information on the use and safety of the ingredient and the product.‣ Product containing multiple ingredients (contains ingredients which areknown to be used traditionally):- The source of the product formulation;e.g. Chinese Pharmacopoeia- Proof or evidence of the use, traditionally.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 241
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Page 190 and 191: Drug Registration Guidance Document
Page 202 and 203: Appearance/organoleptic(odor, color
Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
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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Page 282 and 283: e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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