Department of Health, Executive Yuan, R.O.C. Taiwan (DOH) is in order to promote growing and curing the development of the industry. Since 2003, DOH had established the “System Implementation Guide for Electronic Regulatory Submissions and Review” with HL7 Taiwan. Based on the "Guidance for Drug Registration", the DOH has developed the The Electronic Submission Backbone File Specification and released version 1.0 in April 2005, an electronic exchange standard for the submission of regulatory information by applicants for marketing authorisations for medicinal products to the relevant competent authorities has been developed.

In addition to the continued development and maintenance of the electronic submission standards, and in order properly to implement the eCTD from the perspective of the DOH, there are a number of prerequisites. These include development of the necessary business processes to receive and handle electronic submissions (particularly the eCTD); development of policies particularly those with regard to electronic archiving; and development and implementation of an appropriate technical infrastructure and implementation of systems.

The concept of Electronic Submission and the use of electronic format of files were firstly introduced by pharmaceutical companies in coordination with DOH, under the auspices of International Conference on Harmonisation (ICH). ICH has agreed on certain rules and requirements for a structured submission of electronic files. The aim of Electronic Submission is focused on the minimization of paper use during the exchange of information between applicants and facilitation of business process.