Example: biology
GHTF SG1 - Summary Technical Documentation (STED) for ...
The AHWP has established the Common Submission Dossier Template (CSDT), based on the GHTF STED for medical devices. A requirement for the CSDT has been included into the draft of the ASEAN Medical Device Directive and will become the format of premarket submissions for ASEAN once the directive is implemented.
Tags:
Information
Domain:
Source:
Link to this page:
Related documents
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).
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 ラインで …
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 ...