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ACTD ASEAN COMMON TECHNICAL DOSSIER - Food and …

One vision one identity one communityASEANCOMMONTECHNICALDOSSIERACTD ACTDASEAN: A Community of COMMON TECHNICAL DOSSIER (ACTD)The ASEAN SecretariatJakartaThe Association of Southeast Asian Nations ( ASEAN ) was established on 8 August 1967. The Member States are Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar, Philippines, Singapore, Thailand and Viet Nam. The ASEAN Secretariat is based in Jakarta, inquiries, contact:The ASEAN SecretariatCommunity Relations Division (CRD)70A Jalan SisingamangarajaJakarta 12110 IndonesiaPhone : (62 21) 724-3372, 726-2991 Fax : (62 21) 739-8234, 724-3504E-mail : Catalogue-in-Publication DataASEAN COMMON TECHNICAL DOSSIER (ACTD)Jakarta, ASEAN Secretariat, December 2016 ASEAN Guideline2.

ACTD 3 THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) fOR THE REGISTRATION Of PHARMACEUTICALS fOR HUMAN USE ORGANIZATION Of THE DOSSIER PREAMbLE This ASEAN Common Technical Dossier (ACTD) is a guideline of the agreed upon common format for the preparation of a well-structured Common Technical Dossier (CTD) applications that will …

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www.fda.gov.ph

INTRODUCTION 1 2. OBJECTIVES 1 3. SCOPES 1 4. DESIGN 1 4.1. General 1 4.2. ... Drug Products Intended for Storage in a Freezer 11 ... for a dose delivery system). The analytical procedure should be fully validated and stability indicating according to ASEAN guideline on Analytical Validation. Whether and

  Guidelines, Introduction, Study, Drug, Stability, Delivery, Asean, Asean guideline on stability study of drug

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www.fda.gov.ph

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www.fda.gov.ph

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