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

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

Happy Holidays – Year in Review

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