CA: Health Canada announces completion of pilot phase for hybrid filing format

Health Canada announced that the pilot phase for the hybrid filing format (eCTD submissions, accompanied by partial paper-based submission) has been completed. Since June 2006, a total of 43 hybrid submissions were received and a decision has been reached on 21 of those submissions. 

According to Health Canada, the average number of days to approval for three pharmaceutical hybrid New Drug Submissions (NDS) was 389 days - which it falls well within the range of approval times for paper based CTD submissions (226 - 798 days in 2007 & 2008). Accordingly, Health Canada comes to the conclusion that reviewing a submission in eCTD format has no negative impact on approval times.

Benefits that were realised include:

• Facilitated access to submissions
• Enhanced navigation through submissions
• Faster search/retrieval of information;
• Usage of annotations, highlights and comments
• Copy & paste funtionality

According to Health Canada the hybrid pilot was a success. As a consequence  the authority now strongly recommends electronic submissions in eCTD format. Furthermore, Health Canada will no longer accept eCTD submissions in co-submission filing formats with immediate effect.  Equally, sponsors are no longer required to submit a request prior to filing an eCTD submission in the hybrid filing format.

[Source: Health Canada website]

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