As of 2019, the Chinese Food & Drug Administration (CFDA) has announced that eCTD will become mandatory for electronic submissions within China. Life science organizations that have not yet begun preparing for the new regulatory requirements are advised to act quickly to meet the upcoming deadline.
With eCTD being relatively new in Asia, the transition process comes with a unique set of challenges. Industry and regulatory authorities alike know little about eCTD, and very few in the region have actual practical experience working with the standard. To ensure compliance with eCTD, organizations will need to re-engineer many of their existing business and regulatory processes in addition to selecting, installing, and training staff on appropriate eCTD production and management software.
Being a long-time global standard, EXTEDO has been working with eCTD since its inception. As members of HL7 and ISO, EXTEDO’s experts were directly involved in the development of eCTD. Our team has over two decades worth of practical experience, unprecedented technical knowledge, and valuable insights into the regulatory processes of both authorities and life science companies alike. This guarantees that eCTD submissions created with EXTEDO software always comply with the local regulatory authorities’ validation requirements.
With more than 40 customers in Asia, a strong partner base in the region, and a local office in Shanghai, EXTEDO delivers a truly local experience to our clients. We now offer local support staff and online and onsite training options (all conducted in Chinese) and will shortly deliver our eCTD software, eCTDmanager, with a localized Chinese interface.
EXTEDO's regulatory software is the eCTD software of choice for more than 600 hundred companies and is trusted by over 35 regulatory authorities worldwide. Over the years, we have been able to achieve a proven short implementation phase and quick onboarding for customers. Make sure you benefit from our first-hand, practical experience with eCTD!
eCTDmanager goes beyond basic eCTD submissions software - it provides users with a complete regulatory dossier assembly environment that enables them to operate in a compliant manner within a heavily regulated environment. Its intuitive interface allows for the easy handling of electronic submissions without prior knowledge of XML technology, and its unique visual aids provide context, ensuring simplified completion and unprecedented accuracy.
eCTDmanager provides DMS integrations with BIOVIA, Microsoft SharePoint, OpenText Content Server and Documentum (formerly EMC² Documentum), Veeva, Alfresco, and several other document management systems.
Available both as an in-house or hosted solution, eCTDmanager ensures you will be prepared for upcoming regulatory and technical changes, like the introduction of future standards such as eCTD v4.0. EXTEDO’s submission management suite reduces the time and effort involved in generating, publishing, managing, and (re)-viewing validated electronic submissions.
For further information on using EXTDO solutions with your business, please reach out to us, and someone from our local Chinese team will return your call.