Search results with tag "Asean common technical dossier"
ACTD ASEAN COMMON TECHNICAL DOSSIER - Food and …
www.fda.gov.phACTD 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 …
ACTD ASEAN COMMON TECHNICAL DOSSIER
asean.orgDOSSIER ACTD ACTD ASEAN: A Community of Opportunities ASEAN @ASEAN www.asean.org ASEAN. ASEAN COMMON TECHNICAL DOSSIER (ACTD) The ASEAN Secretariat Jakarta. The Association of Southeast Asian Nations (ASEAN) was established on 8 August 1967. The Member States are Brunei Darussalam, Cambodia, Indonesia, Lao PDR, …
THE ASEAN COMMON TECHNICAL DOSSIER …
www.hsa.gov.sgTHE 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
Guide to Application for Registration of Medicinal Products
moh.gov.bn3.3 Registration Dossier 3.31 All applications for medicinal product registration are to be made by submission of the required documents which are in line with the ASEAN Common Technical Dossier (ACTD) for the registration of pharmaceuticals for human use and ASEAN Common Technical Requirements (ACTR).
THE ASEAN COMMON TECHNICAL DOSSIER …
www.hsa.gov.sgthe asean common technical dossier (actd) for the registration of pharmaceuticals for human use part ii: quality
平成29年度 アジア諸国医薬品・医療機器規制情報収集・分析 …
www.pmda.go.jpACTD（The ASEAN Common Technical Dossier for the Registration of Pharmaceuticals for Human Use）は、上記取り組みを 踏まえてASEAN諸国で合意され、2009年1月から施行された、ASEAN諸国の行政庁に「ヒト用医薬品」の薬事申請を行う際の、申請様式のガイド
PHILIPPINE VARIATION GUIDELINES
www.fda.gov.phClinical documents as per ASEAN Common Technical Dossier (ACTD) part IV (where applicable). 8 MaV-2 Change of content of product labeling C 1. Product labeling refers to Package Insert (PI), Patient Information Leaflet (PIL), unit carton label, inner label and/or blister strips. 2. The change is not a minor variation and not within the scope of ...
ASEAN GUIDELINE FOR THE CONDUCT OF BIOEQUIVALENCE …
asean.org- ASEAN Common Technical Dossier - ASEAN Analytical Validation Guidelines - Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to establish Interchangeability (WHO) - Guideline on Bioanalytical Method Validation (EMEA/CHMP/EWP/ 192217/2009 The guideline should also be read in conjunction with relevant ...