Regulatory Understanding of CTD and ECTD Formate and Preparation of ECTD Submission For South Africa Using Different ECTD Software

Abstract

ICH CTD format provides harmonized format for product registration across the globe. As part of the global point of view, electronic submissions serve as an efficient link between industry and regulators, improving navigation, integrity, and lifecycle management. The eCTD standard specifies a message format and protocol for transmitting submission documents and processing instructions to a system managed by an agency. The XML backbone is a significant element of eCTD since it maintains metadata in submission and provides subsequent navigational ease. South Africa has the biggest economy among countries in the African region. The pharmaceutical business is growing rapidly in RSA. SAHPRA is the government body regulating all healthcare products across the South Africa. This thesis deals with study of requirements for filing eSubmission in South Africa and associated technical regulations with the help of different eCTD software like KnowledgeNet, eCTD Global and Lorenz eValidator which helps in regulatory submission, document management and validation of eSubmission. ICH eCTD v4.0 is coming up with the major changes which will eventually help in making eSubmission easier for companies and easy reviewing process for the regulatory authority. Present thesis elaborated stepwise preparation of eCTD submission for South Africa using eCTD software