Regulatory Blog

The UK regulatory landscape for medicines is increasingly evolving to integrate environmental protection alongside public health safety, and recently, on 1 April 2026, the UK MHRA updated its guidance on " Environmental Risk Assessments in medicines " . A key component of this approach is the requirement for Environmental Risk Assessments (ERA), ensuring that medicinal products do not pose unintended risks to ecosystems during their lifecycle. Background Environmental Risk

The U.S. Food and Drug Administration (FDA) has issued updated guidance in 2026 to help drug manufacturers effectively respond to FDA Form 483 observations issued at the conclusion of CGMP inspections. This guidance focuses on improving communication, investigation quality, and corrective actions, ensuring that manufacturers address compliance gaps while protecting patient safety and product quality. Scope and Purpose This guidance applies to both domestic and international d

The European Medicines Agency (EMA) has introduced two significant guidance updates in 2026, focusing on active substance chemistry requirements  and the emerging use of additive manufacturing (3D printing) in pharmaceuticals . These updates aim to strengthen quality, control strategies, and innovation , while ensuring that pharmaceutical development and manufacturing remain scientifically robust and patient-focused. Guidance: Chemistry of Active Substances Scope and Regulato