In an effort to reduce the costs, Health Canada announced that it is only accepting administrative regulatory submissions in either electronic common technical document (eCTD) format or as a Portable Document Format (PDF) file beginning June 1, per a recent article on in-pharmatechnologist.com. Use of the electronic submission system will make the documents immediately accessible to Health Canada staff and will help improve efficiency within the process. Security issues are not expected to be a problem, as the regulatory body has “a secure electronic viewing and storage tool for drug submissions which has been successfully used for over 5 years,” according to William Wells of Health Canada. To read the full article, click here.
Obstacles Facing Biosimilars
Still in its infancy in the U.S., the industry faces some growing pains.
Life Science Accelerated
Our experts are dedicated to expediting life science product development regulatory pathways.