In their gradual adoption of full electronic submissions in eCTD format, Health Canada recently conducted a pilot to assess the impact of the hybrid filing format. A hybrid submission is a submission in eCTD format that is accompanied by Modules 1 and 2 in paper-based CTD format. The results were published on January 27th, 2010.
Throughout the pilot, initiated in June 2006, Health Canada constantly monitored the progress of the hybrid submissions through the review process. After the pilot had been completed, a survey questionnaire was circulated to both the Therapeutic Products Directorate (TPD) and Biologic and Genetic Therapies Directorate (BGTD) regulatory staff involved in the pilot. The survey assessed three aspects of the pilot: 1) electronic data readiness to assess the training received, 2) working with the LORENZ docuBridge® viewing tool, and 3) working with submissions in the hybrid filing format. Respondents indicated that they were highly satisfied with reviewing electronic data using docuBridge. In general, significant efficiencies gained in the review process, and some of the benefits listed were:
- Facilitated access to submissions
- Enhanced navigation through submissions via table of contents, bookmarks and hyperlinks
- Faster search/retrieval of information
- The ability to insert highlights and annotations directly in the submissions without altering the original document
- The ability to share comments between evaluators in real-time
- The ability to copy information from the submission and paste it into review reports
Overall, the hybrid pilot demonstrated that reviewers are comfortable working with electronic data in eCTD format and that eCTD submissions do not have a negative impact on the review process.
One key result of the pilot is that Health Canada now strongly recommends electronic submissions in eCTD format. More information about the Health Canada pilot can be found here: Health Canada Hybrid Submission Pilot
About LORENZ docuBridge®
LORENZ docuBridge® is the only product used by both industry and agency and boasts built-in live eSubmission review for agency and industry users alike.
LORENZ docuBridge® is a tried and tested system in over twenty countries and is the largest supplier of eCTDs worldwide. LORENZdocuBridge® is capable of dealing with the various interpretations of the ICH guidelines, as well as varying validation rules that each country and/or region devises for itself. This knowledge is reflected in product design and functionality.
About LORENZ Life Sciences Group
LORENZ Life Sciences Group (www.lorenz.cc) develops and markets software solutions for the Life Sciences market since 1989. LORENZ's solutions are geared specifically for submission assembly, review, publishing, validation and management. As the number one supplier of submission management systems in the world, as well as the largest supplier of eCTDs for U.S., European and Japanese submissions in the world, LORENZ is the technological market leader. With over 160 installations in 20 countries, LORENZ has built a reputable customer base. For more information, please click here to contact LORENZ.
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