FDA and Health Canada plow ahead with eCTD requirements

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

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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 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 represents Continue reading

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FDA releases Guidance on Data Integrity and Compliance with cGMP – Q&A

The recent trend of increasing CGMP violations involving data integrity identified during FDA inspections has created a cause for concern with the agency. This trend is “troubling because Continue reading

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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

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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, Mrs. Cory (President) and 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 agency guidances and draft guidances, ethical reforms and noteworthy changes in the industry to 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 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 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

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FDA Draft Guidance – General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products

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 Continue reading

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