Draft and Consultation Documents

Health Canada released a consultation document setting out Proposed Changes to the Therapeutic Products Directorate's List of Recognized Standards for Medical Devices for consultation in March 2013 (now closed). The document proposes the following changes: (a) the addition of new standards; (b) new editions of currently recognized standards to replace previous editions; and (c) the removal of certain standards. [March 2013]

Health Canada released a Draft Revised Guidance Document for Industry - Review of Drug Names for Look-alike Sound-alike (LASA) Attributes for consultation in February 2013 (now closed). The intent of the revised Guidance is to provide companies with more information on the process to be followed and the information to be submitted to Health Canada with respect to the potential for a proposed drug name to be confused with another drug product authorized for use in Canada. [February 2013]

Selected New Guidance Documents

On May 29, 2013, Health Canada released the final version of the Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications to provide guidance to all sponsors seeking authorization to sell or import a drug for the purpose of a clinical trial in Canada. [May 2013]

Changes to the Food and Drug Regulations in re: The extension of Good Manufacturing Practices (GMP) to Active Pharmaceutical Ingredients will come into force on November 8, 2013. [May 2013]

On March 4, 2013, Health Canada released the Guidance Document: Factors Influencing the Classification of Products at the Device-Drug Interface. This document addresses the classification of products at the device-drug interface using an approach that considers the Food and Drugs Act's definitions of "drug" and "device" in a contextual manner. [March 2013]

As of February 2013, Health Canada will no longer issue new Exemption Numbers (ENs) for Natural Health Products (NHPs) in re: The Inspectorate's Natural Health Products Compliance and Enforcement Policy (POL-0044). [January 2013]


CADTH Reinstatement of Pre-Submission Meetings following the temporary hold. Sponsor may now request a pre-submission meeting. [May 2013]