UK Advances Decentralised Manufacturing with New GMP Guideline The UK’s MHRA has released a 2025 guideline on Good Manufacturing Practice (GMP) for decentralised manufacturing (DM), ensuring safe, high-quality medicinal products at point-of-care (POC) and modular manufacturing (MM) sites. Key requirements include UK-based Control Sites holding MHRA licenses, robust Pharmaceutical Quality Systems (PQS) using Quality Risk…

FDA’s New Transparency Initiative The U.S. Food and Drug Administration (FDA) has released over 200 Complete Response Letters (CRLs) from 2020–2024, providing unprecedented insight into its drug and biological product approval process. This initiative enhances transparency, offering drug developers and the public a clearer understanding of FDA decisions to foster predictability and accelerate innovative treatments.…