FOREWORD
This guidance has been developed by the appropriate ICH Expert Working Group and has been
subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH
Steering Committee has endorsed the final draft and recommended its adoption by the regulatory
bodies of the European Union, Japan and USA.
In adopting this ICH guidance, Health Canada endorses the principles and practices described therein.
This document should be read in conjunction with the accompanying notice and the relevant sections of
other applicable guidances.
Guidance documents are meant to provide assistance to industry and health care professionals on how
to comply with the policies and governing statutes and regulations. They also serve to provide review
and compliance guidance to staff, thereby ensuring that mandates are implemented in a fair, consistent
and effective manner.
Guidance documents are administrative instruments not having force of law and, as such, allow for
flexibility in approach. Alternate approaches to the principles and practices described in this document
may be acceptable provided they are supported by adequate scientific justification. Alternate
approaches should be discussed in advance with the relevant program area to avoid the possible finding
that applicable statutory or regulatory requirements have not been met.
As a corollary to the above, it is equally important to note that Health Canada reserves the right to
request information or material, or define conditions not specifically described in this guidance, in order
to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product.
Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly
documented.

(Version 2004)