Health Canada Confirms Plans for Mandatory Filing in eCTD format

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

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It’s here! CDER and CBER will only accept eCTD for new NDAs, ANDAs, and BLAs

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

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REGXIA INC. SUCCESSFULLY COMPLETES MANAGEMENT ACQUISITION

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

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And we’re back!

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

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EMA – Transitioning to mandatory use of electronic application forms

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

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ICH issues draft document for M8: eCTD Implementation Guide

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

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EMA’s initiative to enhance cooperation on generics is expanded to include regulators from outside the EU

The European Medicines Agency’s (EMA) initiative to share Continue reading

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CDER Launches New Office to Strengthen Quality Control

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

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FDA’s latest guidance available – General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products; Draft Guidance for Industry

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

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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 Continue reading

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