Here are the latest pharmaceutical regulatory updates: *EU Regulatory Updates* - *New Variations Regulation*: The EU Commission has published a new variations regulation, effective January 1, 2025 ¹. - *Draft EU Variation Classification Guideline*: A draft guideline is available for comments until August 23, 2024, and includes PLCM (Post-Launch Change Management) ¹. - *Guidance on Phthalates for Medical Devices*: The EU Commission has updated its guidance on phthalates, including new annexes on alternatives to phthalate plasticizers ¹. - *Artificial Intelligence Act*: The EU Commission has published the final text of the Artificial Intelligence Act, establishing a legal framework for AI in medical devices ¹. *FDA Regulatory Updates* - *Revised Nitrosamines Guidance*: The FDA has revised its guidance on controlling nitrosamine impurities in human drugs, including new information on nitrosamine drug substance-related impurities ¹. - *Digital Health and Artificial Intelligence Glossary*: The FDA has published a glossary of digital health and artificial intelligence terms to support consistent use of terminology ¹. - *Waivers and Exemptions*: The FDA has granted waivers and exemptions for certain trading partners, including manufacturers, repackagers, and wholesale distributors ¹. *ANVISA Regulatory Updates* - *Digital Leaflet and Exemption of Printed Leaflet*: ANVISA has introduced a pilot project allowing for the optional exemption of printed leaflets on medication packages ¹. - *Revocation of Traceability Regulations*: ANVISA has revoked all current traceability regulations in Brazil ¹. - *Optimized Procedure for GMP Certification*: ANVISA has established an optimized procedure for GMP certification, including reliance on equivalent foreign regulatory authorities.