9 Nov, 2009 – Datafarm Inc., a world leading provider of high
performance electronic regulatory submission solutions for the life sciences industry, today
announced that four of the top 10 global pharmaceutical companies as well as emerging and
mid-level life sciences companies use Datafarm’s software and services for production and
delivery of Hybrid electronic Common Technical Document (eCTD) submissions to Health
Canada. Datafarm’s announcement comes on the heels of last week’s 7th Canadian DIA
Annual Meeting where Health Canada stated that, effective immediately, sponsor companies
may submit Hybrid eCTD regulatory submissions for New Drug Submission (NDS) applications
with no prior permission request.

Since 2004, a variety of sponsor organizations have used Datafarm’s eCTD software and
services, delivering in excess of 500 Hybrid eCTD submissions to Health Canada. Included in
these were approximately 20 original NDS’s and numerous clarifax sequences. Daniel Orfe,
Vice President of Global Regulatory Submissions Services at Datafarm said, “This recent
announcement by Health Canada will not only benefit directorates reviewers, but will also
provide sponsors real time access to their regulatory filing information and a clear picture of
their products’ regulatory lifecycle. Datafarm’s breadth of experience uniquely positions us to
assist sponsor companies in their transition to Hybrid eCTD submissions,” concluded Dan.

A Hybrid eCTD as defined by Health Canada denotes that a sponsor company may file an
eCTD submission and provide hardcopy for only Modules 1 and 2. This reduces paper volumes
required for submission, potentially by hundreds of volumes. Prior to last week’s announcement
from Health Canada, a sponsor company would need to notify the agency of their intention to file a Hybrid eCTD. The agency could elect to deny the request. Effective immediately, Health
Canada will accept Hybrid eCTD submissions with no prior permission request.