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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Regulatory Update on ISO Targets 1,4-Dioxane in Cosmeti…
On 7 August 2025, the International Organization for Standardization (ISO) announced the registration of a new project, ISO/AWI 24913, d…
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Indonesia BPOM Revises Drug Registration Rules to Strea…
Published on August 19, 2025, by the Indonesian National Agency of Drug and Food Control (BPOM), Regulation No. 23 of 2025 introduces major…
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