Industry News
Health Canada has published a revised version of “How to demonstrate foreign building compliance with drug good manufacturing practices” (GUI-0080) on July 2, 2025. They have pre-recorded a webinar to outline key changes and provide you with contact information should…
Health Canada has revised the process and associated guidance on “Applications and Service Standards for Drug Establishment Licences” (GUI-0127) on December 4, 2024. The document was formely called “Management of applications and performance for drug establishment licences”. Key changes include:…
FDA is hosting a 3-hour webinar on Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards on November 7, 2023. The purpose is to provide the pharmaceutical industry…
FDA is hosting a webinar on Electronic Systems, Electronic Record, and Electronic Signatures on April 25, 2023. This is your opportunity to get information on FDA’s thinking regarding 21 CFR Part 11 and its application to electronic systems, records and…
FDA has published Guidance “Q13 Continuous Manufacturing of Drug Substances and Drug Products“ on 1 March 2023 for Industry. The guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on…