The road to implement monumental changes which affect all segments of an industry is often full of roadblocks and milestone achievements, and the move to a fully electronic submission system requiring mandatory e-filing has been no different. For North America’s major regulatory agencies Continue reading
In an announcement made April 24, 2017 Health Canada reaffirmed its intent to transition all regulatory submissions over to eCTD format. Starting Continue reading
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
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 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
As part of Health Canada’s “ongoing efficiency measures and efforts to reduce regulatory burden on industry and transition to an electronic environment, … [Health Canada announced Continue reading
On October 23, 2014, Health Canada released a new Drug Establishment Licence (DEL) Application Form (FRM-033) with instructions. This form supersedes the Continue reading
A Certificate of a Pharmaceutical Product (CPP) is a certificate used by the Health Products and Food Branch Inspectorate (HPFB Inspectorate) “establishing the status of Continue reading
This revised Draft Guidance on Reconsideration of Decisions Issued for Human Drug Submissions is intended to describe the appropriate process to address submission-related disputes and Continue reading
August 7, 2014. Regxia’s clients speak: “Regxia has our heartfelt appreciation and sincere thanks for their effort and achievement in filing our Continue reading