News

• GxP News Regulatory news 30 ottobre 2025

  EMA Frequently asked Questions about Parallel Distribution (Rev. 6, Oct 2025)

• Regulatory news GxP News 30 maggio 2025

  GMP/GDP Inspectors Working Group (GMP/GDP IWG) Concept paper on the revision of Part IV Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products

• Regulatory news GxP News 11 maggio 2024

  EMA GMP/GDP Inspectors WG releases its 2024 -2026 Work Plan

• Autorità nazionali 11 dicembre 2023

  Proroga della validità dei certificati EU GMP e GDP sino al 2024

• GxP News Regulatory news 1 settembre 2023

  FDA Guidance on Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies

• GxP News Regulatory news 1 settembre 2023

  FDA Guidance for enhanced Drug Distribution Security at the Package level under the Drug Supply Chain Security Act

• Normativa europea 3 novembre 2021

  Approfondimento sulla nuova revisione della "Compilation of Union Procedures on Inspections and Exchange of Information"

• GxP News 27 ottobre 2021

  IPEC: AGGIORNATA LA GUIDA AGLI AUDIT GDP PER GLI ECCIPIENTI

• GxP News 27 ottobre 2021

  Europe: EMA Issues Revised Procedures on GMP/GDP Inspections & Exchange of Information

• Normativa europea 1 ottobre 2021

  Integrazione di EudraGMDP con l'Organisation Management Service (OMS) dell'EMA