DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)ACKNOWLEDGEMENTSThe National Pharmaceutical Control Bureau acknowledges its indebtedness to themembers from the industries, government agencies and universities as statedbelow, who provided comments and advices during the preparation of theseguidelines.Government agencies:i) Bahagian Keselamatan dan Kualiti Makanan (BKKM), KKMii) Bahagian Perubatan Tradisional & Komplementari, KKMiii) Institut Penyelidikan dan Perubatan (IMR), KKMiv) Kementerian Pertanian & Industri Asas Tani Malaysiav) Unit Perancang Ekonomi, Jabatan Perdana MenteriUniversities:i) Jabatan Pemakanan dan Dietetik, Fakulti Perubatan & Sains Kesihatan,Universiti Putra Malaysiaii) Jabatan Pemakanan dan Dietetik, Fakulti Sains Kesihatan Bersekutu,Universiti Kebangsaan Malaysiaiii) Pejabat Dietetik, Pusat Perubatan Universiti Malayaiv) Program Sains Makanan, Fakulti Sains dan Teknologi, Universiti KebangsaanMalaysiaIndustries/ Associations:i) Biotropic Malaysia Berhadii) Direct Selling Association of Malaysia (DSAM)iii) Federation of Chinese Physician and Medicine-Dealers Association ofMalaysia (FCPMDAM)iv) Malaysian Biotechnology Corporation (BiotechCorp)v) Malaysian Dietary Supplement Association (MADSA)vi) Malaysian Direct Distribution Association (MDDA)vii) Persatuan Industri Farmaseutikal Malaysia (MOPI)viii)Persatuan Pengeluar-pengeluar Ubat Tradisional Melayu Malaysia(PURBATAMA)ix) Perubatan Traditional India Malaysia (PEPTIM)x) Pharmaceutical Association of Malaysia (PhAMA)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 238
APPENDIX 5:Drug Registration Guidance Document (DRGD)GUIDELINE ON REGISTRATION OF NATURAL PRODUCTSIMPORTANT NOTES:1. This document shall be read in conjunction with the relevant sections of themain DRGD.2. Natural products will be evaluated based on the criteria for safety and qualityof the product and where appropriate efficacy/ claimed benefits.3. This document is intended to provide guidance for the registration of naturalproducts. However, the document will serve as a living document that will beupdated/ revised further in the line with the progress in scientific knowledgeand experience.4. The following lists are by no means exhaustive. It may be reviewed as andwhen it is deemed necessary.Outline:1. General Information1.1 Definitions1.1.1 Traditional Medicines1.1.2 Finished Herbal Product1.1.3 Herbal Remedy1.1.4 Homeopathic Medicine1.2 Exemption from Product Registration1.3 Preparations which are not allowed to be registered1.4 Classification for Specific Active Ingredients1.4.1 Products Containing Cassia/ Senna1.4.2 Products Containing Psyllium Husk/ Plantago OvataNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 239
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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