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GMP UPDATING - EU Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 1 Pharmaceutical Quality System

Eu       European Commission Consultation - Stakeholders’ Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 1

Re      Revision of Good Manufacturing Practice (GMP) Guidelines:

  • Chapter 1 Pharmaceutical Quality System

Ä3           3 settembre – 3 dicembre 2025: Invio commenti

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ECHA & REACh - SMEs to apply for company size validation before making REACH submissions

The European Commission has adopted the revised REACH Fee Regulation. Micro, small, and medium-sized...

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Changes to e-submission requirements for CEP applications for 1 November 2025

The European Directorate for the Quality of Medicines and HealthCare (EDQM) has published the requirements...

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US FDA Publishes Filing Checklists to Prevent Submission Delays

The US Food and Drug Administration (FDA) published the internal checklists its staff reference when...

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