All About Toxicology
The European Pharmacopoeia (Ph. Eur.) has announced a landmark regulatory transition in pyrogen testing, marking a decisive move away from animal-based methods. Effective 1 January 2026, the Rabbit Pyrogen Test (RPT) under general chapter 2.6.8 Pyrogens will be completely removed from all Ph. Eur. texts. This regulatory change reflects a broader European commitment to scientific…
The European Union’s Scientific Committee on Consumer Safety (SCCS) has released new preliminary scientific advice on the use of micron-sized particulate silver in cosmetic products, marking a significant regulatory development for the cosmetics industry. The updated assessment reverses earlier safety concerns and confirms that micron-sized silver can be safely used within defined concentration limits, based…
The year 2025 has seen an extensive update to international ISO standards affecting the medical device, healthcare, and life sciences sectors. These revised and newly published standards span biological safety, cleanroom operations, sterilization, implants, dentistry, respiratory care, ophthalmics, health informatics, and additive manufacturing, reinforcing global expectations for patient safety, performance, and risk-based compliance. Biological Evaluation…
The European Union has formally adopted Regulation (EU) 2025/2509 on the safety of toys, replacing the long-standing Toy Safety Directive 2009/48/EC. The Regulation was adopted on 26 November 2025 and published in the Official Journal of the European Union, with the objective of strengthening child protection while ensuring harmonised enforcement across Member States . Unlike…
The U.S. Food and Drug Administration (FDA) has released the draft guidance “Q3E Guideline for Extractables and Leachables,” now open for public and stakeholder comments until 30 January 2026. This draft guideline introduces a comprehensive, globally aligned framework for assessing extractables and leachables (E&Ls) in pharmaceutical products, biologics, and combination medical products. Developed in collaboration…
The much-anticipated sixth edition of ISO 10993-1, the global standard guiding the biological evaluation of medical devices, has officially been released. The updated standard aligns more closely with the risk-based approach of ISO 14971, introducing strengthened emphasis on identifying and mitigating chemical risks associated with medical devices. The revised ISO 10993-1 outlines enhanced principles for…