The presentation “Preparing for First eCTD in ASEAN” was given by Teerapong Cheepchol (Jack), Deputy Managing Director of Factorytalk Co., Ltd. in Bangkok, Thailand, at LORENZ userBridge.14 in Milan, Italy.
Mr. Cheepchol (or Jack as he is known here at LORENZ), who also presented at userBridge.13 last year in Budapest, Hungary, used the userBridge.14 conference to present an update on what was happening in Thailand with regards to the eCTD and electronic submission in general. What might not be known by most people is that ASEAN uses what is called the ACTD (ASEAN CTD) structure or format, which differs in structure when compared to the CTD but still contains more or less the same information as the CTD.
The main topic of his presentation was the announcement that the Thailand FDA had started an eCTD initiative, striving to be the first ASEAN member country to adopt and accept the eCTD submission. The Thai FDA has recognized that the eCTD format is being adopted as a more international standard, and by accepting the eCTD in Thailand, would benefit the pharmaceutical industry in many ways.
The Thai FDA has also started an eCTD Pilot, whereby certain Thai pharmaceutical companies will be allowed to submit official eCTD submissions and receive feedback on those submissions. At the same time, the Thai FDA is working together with Jack’s company – Factorytalk – as well as with LORENZ, to get up and running using the LORENZ docuBridge software. A Thai Module 1 (M1) specification is also being developed by LORENZ, which will help the entire pharmaceutical industry prepare Thai-specific eCTDs in the future.
Jack completed his presentation by giving a fairly thorough overview of the eCTD Pilot project, as well as steps that the Thai FDA have taken in their regulatory processes related to submission review and approval, in order to prepare itself for the eCTD Pilot as well as after the Pilot has been completed. Jack also mentioned that the Thai FDA is going to be looking at adopting the RPS (Regulated Product Submission) in the future for medical device submissions/applications. One bit of information that is important to note is that by 2017, the Thai FDA will accept ONLY electronic submissions! That is not that far away. They are also planning to have an ‘electronic gateway’ set up in the near future, making it much more easier to submit submissions electronically.
What the Thai FDA is doing here could have wider implications throughout the ASEAN region. If the eCTD Pilot is successful, which we believe it will be, more National Drug Authorities in the ASEAN region might also start looking at adopting the eCTD as well, reinforcing the idea even further of the eCTD becoming even more of an international standard.
Written by Michael Schultz, Sales Director Middle East & Asia Pacific at LORENZ Life Sciences Group.