Transcription of DRUG REGISTRATION GUIDANCE DOCUMENT - …
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_____ drug REGISTRATION GUIDANCE DOCUMENT (MALAYSIA) 1 NATIONAL PHARMACEUTICAL CONTROL BUREAU MINISTRY OF HEALTH MALAYSIA PETALING JAYA drug REGISTRATION GUIDANCE DOCUMENT PREAMBLE This drug REGISTRATION GUIDANCE DOCUMENT will serve as the reference guide for both pharmaceutical products for human use and traditional products. It will replace the Guidelines for Application for REGISTRATION of Pharmaceutical Products Third Edition of October 1993 and Garispanduan Permohonan Pendaftaran Keluaran Ubat Tradisional Second Edition, December 1998. The contents of this version include: Updated information relating to administrative requirements and procedures.
drug registration guidance document (malaysia) 1 national pharmaceutical control bureau ministry of health malaysia petaling jaya
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IMPURITIES IN NEW DRUG PRODUCTS, Document, GUIDANCE, Registration, GUIDELINE ON SUBMISSION OF, GUIDELINE ON SUBMISSION OF MANUFACTURING PROCESS VALIDATION, DRUG REGISTRATION, Guidance Document for the Completion, GUIDANCE FOR INDUSTRY ON PREPARATION OF, Guidance for industry on preparation of common technical document, Stability Testing of new Drug, Stability testing of new drug substances and products, Guidance on the homeopathic medicinal products, THE HOMEOPATHIC MEDICINAL PRODUCTS DOSSIER