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Dezember 20025: key takeaways on the critical medicines act, the pharma package and more

 

Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795
– General Approach

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  • MHRA Updated guidance for the International Recognition Procedure (IRP)
  • MDCG 2021-5 Rev. 1 .Guidance on standardisation for medical devices
  • Qualification of novel methodologies (QoNM) for medicinal product development . Procedural Guidance to applicants
  • FDA Guidance for Drug Development
  • Study supporting the monitoring of the availability of medical devices on the EU market. 2 July 2026
  • IMDRF Technical Framework for Artificial Intelligence Life Cycle Management” (IMDRF AIML WG N93 – April 2026)
  • GMP CANÁBIS 2026 : “Formação conduzida com profundo domínio teórico e prático “
  • MHRA Open consultation Draft rare disease therapies regulatory framework

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