How to Successfully Update Your Dossier: A Guide to Post-Approval Variations So, you’ve got the Marketing Authorisation (MA) for your medicinal product! But, let’s be real, it’s not a one-and-done deal. As your product’s lifecycle progresses, you’ll need to make updates to its dossier to ensure it remains compliant with regulatory requirements. What’s a Variation, Anyway? A variation is any change to a medicinal product’s registered dossier, decision granting MA, Summary of Product Characteristics, Package Leaflet, […]
Pharmaceutical companies planning to market their products internationally must navigate a complex web of regulatory submission requirements. While many regions follow the ICH Common Technical Document (CTD) or its electronic version (eCTD), each regulatory authority has its own specifications, processes, and expectations. Understanding these differences is essential for regulatory affairs professionals to avoid delays, technical […]