In October 2011, Health Canada implemented a pilot project for
the use of foreign review assessment information when evaluating
health products seeking market authorization in Canada. While the
use of foreign reviews is not new, Health Canada is seeking to
formalize the practice in areas that already use foreign reviews,
extend the practice to areas that currently do not, and standardize
the practice across the Health Products and Food Branch. In
furtherance of the project, Health Canada recently released a draft Guidance document that is intended to
inform industry of the procedures to follow when including a
foreign review in data packages and to detail changes to the
project that Health Canada will be introducing based on internal
and external comments and suggestions.
The scope of the project has been revised so that it now applies
to New Drug Submissions (including abbreviated and supplemental),
Drug Identification Number applications, Class III and IV Medical
Device Licence applications and amendments, Periodic Safety Update
Reports, Risk Management Plans and Notifiable Changes. Canadian
data packages are still required to contain all of the modules and
materials currently requested by Health Canada; however, foreign
reviews may now be joined to specific components within the
corresponding data package. The integrated applications are
expected to facilitate Health Canada's use of foreign data to
guide its own risk-benefit analysis in evaluating products.
Health Canada will consider data from foreign regulatory
agencies which are similar to itself, such as the US Food and Drug
Administration and the European Medicines Agency. The use of data
from other foreign agencies will depend, in part, on the degree of
similarity between the foreign and Canadian regulatory frameworks.
As foreign data is meant to be complementary, when considering
reviews prepared by foreign agencies, Health Canada has the
discretion to vary the extent to which it references the data. The
approach can range from basing the Canadian regulatory decision on
a critical assessment of a foreign review to not referencing the
foreign data at all. While the same approach may be used for review
of the entire data package, different approaches may also be used
for different components within the same data package.
Interestingly, while companies are not required to file a
foreign review (nor can Health Canada unilaterally decide to delay
the Canadian review until a foreign review is available), the draft
Guidance provides that Health Canada may request a review directly
from the foreign regulator if it is not available from the company.
Importantly, as with other information filed in data packages,
foreign reviews will be subject to the same protection regarding
confidential business information and Access to Information
Overall, the draft Guidance attempts to provide a framework for
more consistent use of foreign reviews in the regulatory review
process of health products in Canada. Interested stakeholders are
advised that comments may be submitted until March 31, 2013. The
draft Guidance document is not expected to be finalized until
fiscal year 2013-2014.
Inquests are something which affect a vast range of NHS and private organisations, as well as individual clinicians, and so we provide a brief overview of recent developments as well as a couple of key potential changes to come.
ARCHE is assessing interest in the setting-up of voluntary cooperation groups in order to facilitate producers, distributors and formulators of biocidal products who are interested in placing on the market biocidal product(s).
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