Common Challenges and Pitfalls in Russian Drug Approvals – Regulatory Affairs for Biomaterials and Medical Devices Common Challenges and Pitfalls in Russian Drug Approvals – Regulatory Affairs for Biomaterials and Medical Devices The regulatory landscape for biomaterials and medical devices in Russia presents unique challenges for stakeholders. This article serves as a comprehensive step-by-step guide for regulatory affairs teams, quality assurance professionals, pharmacovigilance specialists, and chemistry, manufacturing, and controls (CMC) experts involved in drug approval processes. Addressing critical phases such as regulatory pathway selection, dossier preparation, submission, review, and post-approval commitments sheds light on overcoming obstacles inherent in the Russian…