In an announcement made April 24, 2017 Health Canada reaffirmed its intent to transition all regulatory submissions over to eCTD format.
Starting January 1, 2018 all New Drug Submissions (NDSs), Supplemental NDSs (SNDSs), Abbreviated 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 Continue reading
TORONTO, ON – August 15, 2015 – Betty Cory, RAC and Lori Steinhoff – de Munnik, RAC, announced today that they have completed the management acquisition of Regxia Inc., a leading regulatory pharmaceutical and biotechnology consulting company situated in Toronto, Ontario providing full lifecycle regulatory expertise for Health Canada, US Food and Drug Administration and the European Medicines Agency to their clients.
Since co-founding Regxia in 2007 Continue reading
After a brief hiatus The Regxia Review is back and focused on bringing to you the most relevant and up-to-date information and resources. From Continue reading
Electronic submissions have become the preferred method for submitting applications for post-authorization approval among the three regions that are party to the ICH. In February 2004, ICH M2 Expert Working Group has released the eCTD Continue reading
On February 19, 2015, the ICH M8 electronic Common Technical Implementation Guide (eCTD IG) reached step 2b of the International Conference on Harmonization (ICH) process1. Pursuant to the process a draft technical document was issued. This document provides instructions on Continue reading
The European Medicines Agency’s (EMA) initiative to share Continue reading
On January 12, 2015, the FDA Center for Drug Evaluation and Research (CDER) launched the Office of Pharmaceutical Quality (OPQ) as part of its ongoing Quality Initiative. The purpose of the OPQ is to Continue reading
On December 08, 2014, US Food and Drugs Administration (FDA) issued draft guidance for industry entitled “General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.” This guidance provides recommendations to sponsors on how 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 Continue reading