Australia's TGA announces new online submission portal for Clinical Trials Notification (CTN) Scheme. - Datapharm Australia

Big news for Sponsors and CROs today with the announcement from the TGA that they will be accepting online CTN submissions. The TGA Business Services website will be where you go to submit CTN applications directly to the TGA. So what does this all mean for sponsors wanting to perform a clinical trial in Australia?

• Paper-based CTN submissions that are received by the TGA after the 1st of July 2015 will need to be re-submitted through the new online submission process.
• Effectively this means the end of sending paper-based CTN submissions back and forth between the sponsor, the principal investigator and the ethics committee to obtain the necessary signatures. This has been replaced by an online sponsor declaration.
•  Online CTN submissions can be amended as needed with new information.
• Online CTN submissions can be tracked to determine if the submission is still under review or if it has been acknowledged/approved.
• Payments can be made online and invoices can be generated if needed.

Collectively it is hoped that these new benefits will help the TGA to acknowledge CTN submissions much faster. Datapharm Australia is excited to use this new online submission platform and work with sponsors to get their trials started as soon as possible. If you need help using the TGA Business Services website please contact us here or click here for more information from the TGA concerning this update.