eCTD has been around for nearly 20 years and we’ve seen how it has transformed the regulatory submission landscape. The next major evolution in electronic submissions will be the transition from eCTD version 3.2.2 to eCTD version 4.0. Read More
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has gradually evolved, to respond to the increasingly global face of drug development. ICH’s mission is to achieve greater harmonisation worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. Read More
At the ICH M8 EWG meeting in November 2014, the Steering Committee endorsed the M8 EWG to post the ICH eCTD v4.0 DRAFT Implementation Guide v2.0 and related files for regulatory consultation. These documents are now available for regulatory consultation until May 22, 2015 and can be accessed using the following link: Read More
