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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.
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.
The European Medicines Agency (EMA) has updated a guideline on good pharmacovigilance practice (GVP) inspections to reflect changes to the rules on subcontractors.
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its pharmacovigilance procedures guidance with new advice about periodic safety update reports (PSURs).
Australia’s Therapeutic Goods Administration (TGA) has started a consultation into proposed changes to support automated decision making (ADM) for listed medicine variation applications.