Regxia Review

Welcome to the Regxia Review. Your go-to resource for regulatory and quality insights.

Nov 182 min read

Are you ready for Health Canada's mandatory XML PMs?

Health Canada releases notice regarding mandatory filing requirements for XML PMs, starting in 2025.

Oct 12 min read

Update: Health Canada’s Guidance on Drug Submissions for Biologics

Health Canada's updated guidance document combines three CTD guidance documents applicable to conventional biotherapeutic products into one.

Sep 122 min read

Pharmacovigilance / Drug Safety Defined

Pharmacovigilance activities are necessary to ensure the detection, assessment, understanding and prevention of adverse effects.

Aug 292 min read

Updates to Health Canada’s GUI-0119: Manufacture of Sterile Drugs

Health Canada has updated GUI-0119 to help companies comply with GMP for fabricating and packaging/labelling of sterile drugs.

Aug 82 min read

eCTD – Why Outsource?

eCTD is used for regulatory submissions to Health Authorities globally. Partnering with an experienced provider can streamline the process.

May 143 min read

XML PM: What is it and why does it matter to sponsors?

Health Canada's XML PM: What is it? What are the challenges? How can you prepare?