Taipei, Taiwan – EXTEDO, a leading provider of Regulatory Information Management solutions, announced that the Taiwan Food and Drug Administration (TFDA) has decided to use EXTEDO’s agency solutions to review electronic common technical document (eCTD) submissions in the future.
The Taiwan FDA pre-announced the eCTD validation criteria on 16th June 2020 and will follow up with a formal announcement after they have received feedback from the stakeholders within the Taiwanese medical industry.
The Genetics Generation Advancement Corporation (GGA Corporation), has partnered with EXTEDO to support the Taiwan FDA in their introduction of the eCTD standard within Taiwan.
Following countries such as the USA, EU, Japan, Australia, Canada, and Switzerland, Taiwan will soon adopt the eCTD standard.
“EXTEDO is proud to support already more than 35 regulatory agencies globally reviewing eCTDs and other submission formats. We are excited to play a part in the introduction of eCTD in Taiwan and are honored to support the needs of organizations within the country”, says Martin Schmid, Managing Director of EXTEDO.
EXTEDO’s submission management portfolio will bring effortless Taiwan eCTD compliance and enable the TFDA to review regional electronic submissions quickly and accurately.
The relevant EXTEDO submission management components are:
EURS is a software solution that serves as an overall eCTD validation and reviewing software tool used by more than 35 authorities worldwide. The enhanced EURS solution EURSnext, which Is selected by TFDA, is currently being implemented by more and more authorities globally.
eSUBmanager, the industry version of EURSnext, is used to manage, view, and review submissions. Using the same solution as most authorities provide confidence and reduced risk to the industry.
EURSvalidator is the leading electronic submission validation engine used by more than 35 regulatory authorities and thousands of users worldwide.
eCTDmanager, an easy-to-use solution to build, view, validate, and publish compliant submissions that meet global regulatory specifications.
Genetics Generation Advancement Corporation (GGA), EXTEDO's local partner in Taiwan, does not only focus on delivering and implementing the end-to-end solution for Regulatory Information Management, but we are offering support, consulting, training, and validation for local Taiwanese customers. Our clients have received great value with the EXTEDO solutions; they appreciate the user-friendly functionality which allows them to submit high-quality submissions.
Today, EXTEDO’s and GGA’s strong collaborative partnership helps many customers to deliver compliant eCTD submissions effortlessly. We are proud to announce that we are assisting the Taiwan FDA (TFDA) in establishing a submission management solution system, which will enable the automation of the submission, validation, and decision-making process.
Being a trusted EXTEDO partner, we have gained practical experiences to enable us to provide consulting services for TFDA in the discussion of eCTD specification and validation criteria.
For more information, please visit www.gga.asia.
EXTEDO is a leading solutions and services provider in the field of Regulatory Information Management (RIM). We focus on optimizing our clients’ eRegulatory business processes and are the only vendor that provides solutions covering the entire regulatory landscape. Our EXTEDOsuite combines innovation with compliance and quality with usability.
Whether planning & tracking, product registration, submission publishing, and lifecycle management, or pharmacovigilance management and drug safety - we optimize every eRegulatory business process. Today, EXTEDO enables more than 35 regulatory authorities and over 850 maintained customers across 60 countries to deliver Effortless Compliance™.