The Thai Food and Drug Administration (FDA) recently announced an electronic common technical document (eCTD) pilot program for drug application dossiers. The pilot program will start in October 2014. After feedback from the pilot, the Thai FDA’s electronic submission system will be fully implemented in May 2015.
Thailand aims to be the first ASEAN country with a national eCTD program. Use of the eCTD system will make submission of drug dossiers and applications easier for pharmaceutical companies. The Thai FDA’s application review timeline will also likely be shortened.
Thailand’s eCTD program is based on International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), European Union and Canadian specifications and guidelines. The Thai system should also be compatible with the Association of Southeast Asian Nations (ASEAN) common technical document (ACTD) initiative.
When the new system is implemented in 2015, existing applications will not be affected — paper applications will still be accepted. However, the Thai FDA has announced that only electronically submitted applications will be accepted by 2017. Furthermore, it is very likely that the eCTD system will also be extended to medical device applications in the next several years.