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
In just a few days, May 5, 2017, the FDA will only accept eCTD formatted submissions for New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), and Biologics License Applications (BLAs). Passing this milestone represents 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
The European Medicines Agency’s (EMA) initiative to share agency assessments reports, aims to facilitate the timely authorization and availability of safe, effective and high quality generic medicines in support of the International Generic Drug Regulators Pilot (IGDRP), and has now expanded to include regulatory agencies worldwide.
The IGDRP was created in 2012 to 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
The introduction and acceptance of electronic submissions as the preferred submission process has been adopted at varying rates by different jurisdictions within the three ICH regions over the past several years. This move to provide a harmonized format has 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 08, 2014, the FDA issued a draft guidance for industry entitled “Critical Path Innovation Meetings.” The Critical Path Innovation Meetings (CPIM) provides an opportunity for FDA’s Center for Drug Evaluation and Research (CDER) to discuss Continue reading