Health Canada recently announced the implementation of ICH guidance E18: Genomic Sampling and Management of Genomic Data (the “Guidance”).

From September 28th to October 28th 2017, the Therapeutic Products Directorate (TPD) of Health Canada held an online consultation on five proposed initiatives to promote in the approval process for prescription pharmaceuticals.

Effective immediately, no new dental plaque-disclosing product will be allowed in the marketplace without a DIN or an NPN.

The Australia Canada Singapore Switzerland (ACSS) Consortium was established to foster collaboration and synergy between regulatory authorities to address common scientific and regulatory challenges. The consortium consists of several working groups with various projects that aim to address current regulatory issues such as timely access to safe therapeutic products within a limited resource capacity.

On May 7, 2018 Health Canada published a notice announcing the start of a 90-day consultation on the submission of Master Files in eCTD format.

Health Canada is continuing to work towards the target date of January 1, 2019 to transition to MDSAP Quality Management System certificates being accepted for medical device licence applications.

Health Canada has announced the implementation of the ICH guidance E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population (the “Guidance”). In implementing the Guidance, Health Canada endorses the principles and practices described in the addendum.

Digital health technologies are a rapidly growing area in the area of healthcare. These technologies encompass a wide range of products, from single software applications to wearables, and to hardware systems that can been connected to smartphones and computers.

The International Medical Device Regulators Forum (IMDRF) recently published a Proposed Guidance Document titled Definitions for Personalized Medical Devices (the “Guidance”). The Document is open for public consultation and has been posted on the IMDRF website for comments from the public.

Manufacturers who sell medical devices in the Canadian market are required to submit MDSAP certificates by December 31, 2018. The Medical Device Single Audit Program (MDSAP) is an international harmonization initiative that allows a single audit to meet the regulatory requirements of five jurisdictions (Canada, United States, Brazil, Australia and Japan).

On April 4th, 2018 Heath Canada issued a Notice to announce its implementation of the ICH Q11 final guidance document on Questions and Answers: Selection and Justification of Starting Materials for the Manufacture of Drug Substances. This version of ICH Q11 Question and Answers was initially published in August 23, 2017 by the ICH Expert Working Group.

Health Canada recently announced the implementation of the ICH Guidance “Q3C(R6) Impurities: Guideline for Residual Solvents” (the “Guidance”).