Health Canada Issues a Guidance Document on the Preparation of Drug Regulatory Activities in the “Non-eCTD Electronic-Only” Format

On February 3rd, 2016, Health Canada announced a revision to the guidance on Preparation of Drug Regulatory Activities in the “Non-eCTD Electronic-Only” Format, which was published in September 2015, to include Division 8 drugs and Clinical Trial regulatory activities in “non-eCTD electronic-only” format.

This document outlines the filing requirements and Continue reading

Government of Canada Passes “Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) – Modernized Patient Safety Laws for Drugs and Medical Devices

On December 6, 2013 it was announced that a new patient safety legislation would be introduced known as the “Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law)”. The law is named after Vanessa Young, the daughter of MP Terence Young, who died of a heart attack after taking an unsafe prescription drug…[Read our Original Blog Post Regarding the Announcement of Vanessa’s Law Here]
Since the announcement in 2013 the law has passed and marks a major milestone in Canada’s drug safety history. This Act will Continue reading

Happy Holidays – Year in Review

Happy Holidays to our clients, friends, and family – wishing you a safe and enjoyable winter season.

As we welcome in the holidays we say goodbye to a phenomenal year that saw Regxia go through several pivotal changes that have allowed us to grow and strengthen our commitment to serve our clients.

This past year, we Continue reading