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European Commission Updates Regulatory Affairs Newsletter

European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Biocides: Upcoming active substance renewals, expiries and approvals

Apply for active substance renewal by the deadlines to keep products on the NI market 29 April 2025 Polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1415 and a mean polydispersity (PDI) of 4.7 (PHMB (1415;4.7)) (CAS 1802181-67-4 / 32289-58-0 EC n/a) in product types 2 and 4 30 July 2025 Hydrogen peroxide (CAS 7722-84-1 EC 231-765-0)…
Ben Kemp
February 3, 2025
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EU Health Policy Platform: The 2024 Thematic Networks cycle has come to an end – what’s next?

EU Health Policy Platform: The 2024 Thematic Networks cycle has come to an end – what’s next? The 2024 Thematic Networks are now being transformed into Stakeholder and Exchange Networks, but you can continue to share your views and provide input on the health topics they deal with. The Joint Statements on which the Thematic Networks have been working on…
Ben Kemp
February 3, 2025
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Joint Action on Networks of Expertise on Cancer launched

Joint Action on Networks of Expertise on Cancer launched Today, the second Joint Action of the EU Networks of Expertise on Cancer (JANE-2) has been launched. This is one of the largest Joint Actions on cancer, supported by EUR 40.5 million in funding from the EU4Health programme. JANE-2 has 121 partners from 29 European countries and is coordinated by Italy.…
Ben Kemp
February 3, 2025
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Health Technology Assessment – Commission adopts rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices

Health Technology Assessment - Commission adopts rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices Today, the European Commission adopted an implementing regulation establishing the rules for joint scientific consultations on medical devices and in vitro diagnostic medical devices, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the…
Ben Kemp
February 3, 2025
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MDCG 2023-3 rev.2 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 – January 2025

MDCG 2023-3 rev.2 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 - January 2025
Ben Kemp
January 17, 2025
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UPDATED – MDCG 2023-3 Q&A on vigilance terms and concepts

MDCG have update Guidance MDCG 2023-3 Q&A on vigilance terms and concepts to Revision 2. There have been several editorial changes made to footnote 8 (adapted to gradual roll-out of Eudamed), Q21 (changed reference to ‘Eudamed Postmarket surveillance and Vigilance module (VGL module)’) and Footnote 34 (timeline for FSN clarified). You can find the updated document via the link: https://health.ec.europa.eu/document/download/af1433fd-ed64-4c53-abc7-612a7f16f976_en?filename=mdcg_2023-3_en.pdf…
Ben Kemp
January 16, 2025
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The first six EU reference laboratories for public health are now operational

The first six EU reference laboratories for public health are now operational Since 1 January 2025, the first six EU reference laboratories (EURLs) for public health have been operational and will now carry out activities for the next seven years. The EURLs, which bring together consortia of scientific expertise from across the EU, contribute to improving EU preparedness and ensuring…
Ben Kemp
January 9, 2025
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Health Technology Assessment – Commission adopts rules for joint scientific consultations on medicinal products for human use

Health Technology Assessment - Commission adopts rules for joint scientific consultations on medicinal products for human use Recently, the European Commission adopted an implementing regulation setting out the rules for joint scientific consultations on medicinal products for human use at Union level, under the Health Technology Assessment (HTA) Regulation. The implementing act provides detailed procedural rules for the joint scientific…
Ben Kemp
January 9, 2025
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