Italy’s AIFA Updates Guidance on OTC and Non-Prescrip…
On February 23, 2026, the Italian Medicines Agency (AIFA) published revised guidance clarifying the definition and classification of over-th…
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Bahrain NHRA Publishes Updated Medicine Variations Guid…
On January 21, 2026, the National Health Regulatory Authority (NHRA) published an updated Medicine Variations Guideline for Human Medicines.…
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UK MHRA Issues Guidance on Pharmacovigilance Requiremen…
On 9 February 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) published new guidance for UK Marketing Authorisation …
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FDA Launches ImportShield Program to Strengthen Oversig…
On January 21, 2026, the U.S. Food and Drug Administration (FDA) announced the launch and initial results of the FDA ImportShield Program (F…
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Malaysia MOH Mandates New FarmaTag Hologram Label for P…
On December 17, 2025, the Ministry of Health Malaysia (MOH) announced a regulatory update introducing a new FarmaTag hologram security label…
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EMA Updates Guidance on Post-Approval Change Management…
On 11 December 2025, the European Medicines Agency (EMA) published revised guidance on Post-Approval Change Management Protocols (PACMPs), u…
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EU Announces Landmark Reform of Pharmaceutical Legislat…
On 11 December 2025, the European Commission announced a political agreement on a major reform of EU pharmaceutical legislation, marking the…
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US FDA Announces Deployment of Agentic AI Capabilities …
On December 1, 2025, the U.S. Food and Drug Administration (FDA) announced the deployment of new agentic AI capabilities to enhance pre-mark…
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EU Council Approves Postponement of Chemical Packaging …
On 17 November 2025, the Council of the European Union approved a regulation postponing several upcoming compliance deadlines under the revi…
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Global Regulators Confirm No Link Between Paracetamol U…
Between September 23–26, 2025, multiple health authorities, including Singapore’s Health Sciences Authority (HSA), Australia’s Therape…
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