Part I. Table of Contents, Administrative Data and Product Information Part I contains initially the overall Table of Contents of the whole ACTD to provide basically the information that could be looked through respectively. Secondly, the next...
Part I. Table of Contents, Administrative Data and Product Information Part I contains initially the overall Table of Contents of the whole ACTD to provide basically the information that could be looked through respectively. Secondly, the next content is the Administrative Data where required specific...
Part I contains initially the overall Table of Contents of the whole ACTD to provide basically the information that could be looked through respectively. Secondly, the next content is the Administrative Data where required specific documentation in detail is put together such as application forms, lab...
Part I contains initially the overall Table of Contents of the whole ACTD to provide basically the information that could be looked through respectively. Secondly, the next content is the Administrative Data where required specific documentation in detail is put together such as application forms, lab...
2.Section B: Table of contents Certifications: Certificate of GMP, Certificate of Free Sale ,from the the FDA and certified by Thai embassy in that manufacturer country.3.Section C: Documents required for registration 3.1 Reference of Pharmacology of Product.1.Pharmacodynamics/Pharmacokinetics.2....
Table of Contents99999--Section B. Clinical Overview99999-- 1.Product Development Rationale 2.Overview of Biopharmaceutics 3.Overview of Clinical Pharmacology 4.Overview of Efficacy 5.Overview of Safety 6.Benefits and Risks Conclusions Section C. Clinical Summary99999--1.Summary of Biopharmaceutic ...
ACTD_OrganizationofDossier THE ASEAN COMMON TECHNICAL DOSSIER (ACTD) FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ORGANIZATION OF THE DOSSIER
GUIDANCE ON MEDICINAL PRODUCT REGISTRATION IN SINGAPORE – APPLICATION CHECKLIST 3A (ACTD - NDA AND GDA) FEBRUARY 2012 Part I – Administrative Documentation Application Type & Evaluation Route Section Documents NDA Full 1.1 Comprehensive Table of Contents Abridged Verification Abridged GDA Verification ?
1.1ComprehensiveTableofContents IncludeacompletelistofalldocumentsprovidedintheapplicationdossierbyPart ThelocationofeachdocumentshouldbeidentifiedbythePartnumber Foranydocumentssubmittedinhardcopy,thelocationofeachdocumentshouldbe identifiedbythevolumenumberandtabidentifiers(nameofdocumentorsection headingaccordingtoACTDformat...
SECTION B: TABLE OF CONTENTS A table of contents for the filed application should be provided. SECTION C: BODY OF DATA S S1 DRUG SUBSTANCE GENERAL INFORMATION S 1.1 Nomenclature - International non–proprietary name (INN) - Compendial name if relevant - Registry number of chemical abstract ...