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ÚLTIMAS NOTICIAS
EUDAMED Release note v 2.18.0
Oct 16, 2025 The new version of EUDAMED 2.18.0 has been deployed.
The ICH E2D(R1) Guideline reaches Step 4 of the ICH Process
24 September 2025 The ICH E2D(R1) Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports” has reached Step 4 of the ICH Process on 15 September 2025 and has now entered the implementation phase...
The impact of the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) to address shortages of human and veterinary medicines across Europe
Shortages of medicines are a global issue and a critical public health challenge that is at the top of the agenda of EU policymakers, regulators and healthcare providers. The World Health Organization (WHO) and various health authorities worldwide have acknowledged...
The European Medicines Agencies Network Data Strategy
As defined in the Joint HMA-EMA Network Data Steering Group mandate, the European medicines regulatory network handles a wide spectrum of data that is received, processed, generated, managed and analysed to ensure that decisions on medicines are well-informed and...

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