DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO. COUNTRIES6. India (HPI)7. European PharmacopoeiaAttachment 4:List of Endangered Animal Species/ Protected WildlifeAs listed in the Wildlife Protection Act.Notes:These lists are not exhaustive and will be amended from time to time as and whenthe need arisesREFERENCESa) List of Ingredients Prohibited and Restricted in Pregnancy1. Benchmarks for training in traditional Chinese medicine (WHO)2. American Pregnancy Association3. Natural Standards4. Health Canada5. TCM Discovery (Contraindication of Chinese Medicinal Herbs)6. Motherlove Herbal Company (Herbs to avoid while Pregnant)7. Green Earth Herbs (Herbs Contraindicated in Pregnancy)8. Home. Caregroup.Org (Herbs during Pregnancy and Lactation)b) Homeopathic Products:1. Safety Issues in the Preparation of Homeopathic Medicines, World HealthOrganization, 2009.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 308
Drug Registration Guidance Document (<strong>DRGD</strong>)APPENDIX 6:GUIDELINE ON REGULATORY CONTROL OF ACTIVEPHARMACEUTICAL INGREDIENTS (API)(Version 2.1)Outline:1. Introduction2. Definition2.1 Definition of Active Pharmaceutical Ingredient (API)2.2 Classification of Active Pharmaceutical Ingredient (API)3. Scope4. Procedure for Submission4.1 How to Submit4.2 Required Information4.3 Other Considerations4.4 Processing Fee5. Drug Master File (DMF)6. Certificates of Suitability (CEP)7. Full Details of API Information in the Product Dossier Application8. Stability Data of API9. Site Inspection10. Maintenance of Approval StatusNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 309
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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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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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