Today's pharmaceutical industry is constantly evolving, with regular updates on regulations, guidelines, and new technologies. Here are some recent updates: *Regulatory Updates* - *New Variations Regulation*: The EU Commission has published a new variations regulation, effective January 1, 2025 ¹. - *Artificial Intelligence Act*: The EU Commission has published the final text of the Artificial Intelligence Act, which establishes a legal framework for the use of AI in medical devices ¹. - *Guidance on Phtalates for Medical Devices*: The EU Commission has updated its guidance on the benefit-risk assessment of phthalates in medical devices ¹. *Guideline Updates* - *EMA Guidance on Environmental Risk Assessment*: The European Medicines Agency (EMA) has updated its scientific guideline on environmental risk assessment of medicinal products for human use ¹. - *FDA Guidance on Nitrosamine Impurities*: The US Food and Drug Administration (FDA) has revised its guidance on controlling nitrosamine impurities in human drugs ¹. *Industry Developments* - *Use of AI in Pharmaceutical Development*: The EMA has published a reflection paper on the use of artificial intelligence in the medicinal product lifecycle ¹. - *Digital Health and Artificial Intelligence Glossary*: The FDA has published a digital health and artificial intelligence glossary to support consistent use of terminology ¹.