The Pharmaceuticals and Medical Devices Agency (PMDA) has published advice on ensuring the safety of healthy adult participants in Japanese bioequivalence studies.
Australia’s Therapeutic Goods Administration (TGA) has adopted two new medicine labeling standards, starting a five-year countdown to mandatory compliance with the updated requirements.
The Indian government has approved a program for monitoring adverse events associated with medicines and biological products used in organ and tissue transplantation.
Emer Cooke and other EMA leaders have weighed into the debate about whether sponsors should run one or two pivotal trials, arguing that the decision should be informed by the evidence needed to show a positive benefit-risk balance.
Officials from the US Food and Drug Administration (FDA) reaffirmed the administration's priorities in the proposed commitment letter for the Prescription Drug User Fee Act (PDUFA VIII) program during a public meeting on Wednesday.
CHARLOTTE, NC — Officials from the European Commission and European Medicines Agency (EMA) touted key reforms presented in the proposal to overhaul the bloc’s pharmaceutical legislative framework during a panel discussion at RAPS Convergence 2026.
A commission set up by the Medicines and Healthcare products Regulatory Agency (MHRA) has shared 44 recommendations about the future regulatory framework for AI in the UK.
Singapore’s Parliament has advanced legislation to build “a more coherent, future-ready system” that provides clarity and predictability for the healthcare industry.
