DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)1.1.1 REGISTRABLE PRODUCTSAny product as defined in 1.1 shall be registered with the Authority.The products include, but not limited to the following:a) Pharmaceutical products containing scheduled poisonsb) Pharmaceutical products containing non-scheduled poisons(For examples: Medicated plaster with medicine, antiseptic/ disinfectants for useon the human body, diagnostic agents for human use (in-vivo) and healthsupplement such as probiotics and chitosan)c) Natural productsIncludes herbal and traditional products1.1.2 NON-REGISTRABLE PRODUCTSi) Diagnostic agents and test kits for laboratory/ in-vitro useDiagnostic agents/ test kits for laboratory use must be labeled „FORLABORATORY USE ONLY‟.Note:Products which are not labelled as such shall be deemed to be for human oranimal use and need to be registered with the Authority.ii)Medical Devices“Medical device” means any instrument, apparatus, implement, machine,appliance, implant, in vitro reagent or calibrator, software, material or othersimilar or related article intended by the manufacturer to be used, alone or incombination, for human beings for the purpose of:National Pharmaceutical Control BureauFirst Edition, January 201328
Drug Registration Guidance Document (<strong>DRGD</strong>)(i) diagnosis, prevention, monitoring, treatment or alleviation of disease;(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury;(iii) investigation, replacement or modification, or support of the anatomy or of aphysiological process;(iv) support or sustaining life;(v) control of conception;(vi) disinfection of medical device; or(vii) providing information for medical or diagnostic purpose by means of in vitroexamination of specimens derived from the human body,These products do not achieve its primary intended action in or on the humanbody by pharmacological, immunological or metabolic means, but that may beassisted in its intended function by such means.This includes but is not limited to the following:- Non-medicated bandages, plaster- Surgical dressings, wound care/ dressing materials containing hydrogel,collagen, calcium alginate- Visco-elastic products for mechanical or physical protection of tissues duringor after surgical procedures- Instruments, apparatus, syringes, needles, sutures, catheters- Disinfectants for equipments/ devices- Lubricants for gloves, condoms and endoscopes- Contact lens care products- Copper IUDs- Bone cement, tissue adhesives- Dental fillings- Blood bags containing anti-coagulants- Non-medicated medical and contraceptive devicesFor more information, please refer Medical Device Bureau.National Pharmaceutical Control BureauFirst Edition, January 201329
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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