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The first harmonised standard under the EU AI Act is here
On 14 October 2026, the European Commission published the reference to EN 18286:2026 in the Official Journal of the EU 👉 https://lnkd.in/dkte6BZB With Commission Implementing Decision (EU) 2026/2274, the reference to EN 18286:2026 "Artificial...
PHARMA PACKAGE : Council adopts new rules for a fairer and more competitive EU pharmaceutical sector
The Council has adopted the ‘pharma package’, a new set of rules that will increase patients’ access to medicine and make the EU’s pharmaceutical sector fairer and more competitive. The package represents a far-reaching reform of the EU’s pharmaceutical legislation...
HTA Regulation – Commission selects first medical devices for joint clinical assessment
The Commission has adopted its first decision to select two medical devices for joint clinical assessment under the EU Health Technology Assessment (HTA) Regulation. The two devices are both addressing cardiovascular disease. One of the selected devices is the SAPIEN...
PHARMACOVIGILANCE UPDATE | FDA E2B(R3) IMPLEMENTATION GUIDE — OCTOBER 2026
The FDA has published an updated version of the ICH E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide. FDA has adopted the E2B(R3) data standards, and the documents listed below reflect FDA’s recommendations for...
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