Regulatory round-up: 19 January 2026

Global regulators have ushered in 2026 with a slate of drug approvals, policy shifts and collaborative initiatives, including first-ever treatments for rare conditions and expanded use of existing medicines. At the same time, major authorities rolled out reforms to accelerate patient access and more.

In the USA, the Food and Drug Administration (FDA) authorized a groundbreaking pediatric rare-disease treatment and issued new guidance frameworks to modernize clinical trials and gene therapy regulation. 

Across the Atlantic, the European Medicines Agency (EMA) partnered with the FDA on guiding principles for AI in drug development, while its safety committee maintained vigilant pharmacovigilance. National regulators in Europe similarly implemented updated EU guidelines and legislative changes affecting drug variations and pricing, ensuring alignment with evolving standards.