Health Canada has released a document summarizing consultations with stakeholders which took place this summer in respect of the regulatory framework for subsequent entry biologics. The summary report sets out the key discussion topics and feedback received from stakeholders and other interested participants.

For more information, please see the English and French versions of the report that can be found at the links below:

http://clf2-nsi2.hc-sc.gc.ca/dhp-mps/pubs/biolog/2008-consult-seb-pbu-rep-rap/index-eng.php

http://clf2-nsi2.hc-sc.gc.ca/dhp-mps/pubs/biolog/2008-consult-seb-pbu-rep-rap/index-fra.php