Factorytalk Co., Ltd. together with their software partner LORENZ has completed a pilot project for the Thai Food and Drug Administration (FDA) to implement the first eCTD in ASEAN for electronic applications of drug product registrations.
The project included providing a complete set of software and services to re-engineer and automate the existing procedures to receive, review and process applications and has enabled totally electronic submissions using international standards with a leading global solution. The project was initiated by the Bureau of Drug Control as part of its goal to be fully paperless and now the pilot project is complete.
In 2014, the joint pilot project between FDA and industry was undertaken; this pilot phase comprised of a group of 11 companies with more than 340,000 pages of documentation in total that were submitted successfully within the 2 months project timeline. This marked a highly important milestone and beneficial collaboration between the Thai FDA and the industry.
The Thai FDA are using the LORENZ’s docuBridge software tool to power their complete eCTD review and validation process for 100% of the applications the agency receives. Factorytalk together with LORENZ continues to support major new electronic initiatives at the FDA including the implementation of new Module 1 specifications (2016), further electronic submission requirements and Regulated Product Submissions. In 2015, the Thai FDA have announced that the eCTD will also be the selected and the preferred submission format for NCE (New Chemical Entity) and New Biological products.
Based on the highly successful pilot the Thai FDA are moving further forward to expand the docuBridge solution and usage across additional application types and to increase the accessibility to the solution for external reviewers.
“Now applications can be ready to review within a short time which is impossible for paper submissions, the flexibility and functionality of the solution together with Factorytalk and LORENZ helped us to re-design, simplify and automate our business processes ultimately leading to an increase in the accessibility of medicine. We are now looking forward to rolling out the solution for different application types in the future” said Mr.Vinit Usavakidviree, Senior Advisor in Safety and Efficacy of Health Products – Food and Drug Administration
There was also an excellent response from the industry who participated in the pilot project: “This project by the Thai FDA and Factorytalk has been highly appreciated and we see is providing considerable advantages for the agency and also for the industry. Particularly small and medium-sized companies will benefit to move to electronic submissions to greatly reduce their overheads. The change for us to move from paper to eCTD was seamless and is saving us internally greater than 50% of the previous time to compile an application and we are now receiving the Thai FDA’s ID of acknowledgement within a month”, TO Group Thailand
Teerapong Cheepchol, Deputy Managing Director, Factorytalk Co., Ltd who closely guided and supported the project provided the following statement at the closure of the pilot: “We are very proud that the Thai FDA has trusted and made us part of their eCTD transformation which is a highly prestigious project in ASEAN. Our consultants have greatly appreciated the chance to apply their expertise in international standards and best practices to make significant change in such an important business process for Thailand”