checklist for registration of IND as per ICH CTD format
INTRODUCTION: ABOUT ICH: “International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use”. This project brings together regulatory authorities of Europe, Japan & US, to discuss scientific & technical aspects of pharmaceutical product registration. ICH’s mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high quality medicines are developed, and registered and maintained in the most resource-efficient manner while meeting high standards.1 ICH aims to provide uniform standards for technical requirements for pharmaceuticals for human use. They are developed by regulatory and pharma industry authorities. The purpose of ICH guidelines is to ensure safe, effective, and high-quality medicines are developed and registered efficiently. ABOUT CTD: CTD - Common Technical Document3 The agreement to assemble all the Quality, Safety, and Efficacy information in a common format called CTD has revolution...