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This guideline aims at providing criteria to select medicinal products for which active surveillance for collecting post-authorisation data in pregnancy is necessary. It provides guidance on how to monitor accidental or intended exposure to medicinal products during pregnancy and specific requirements for
This document describes how to assess the risk of an adverse reproductive/developmental effect in human based on reproductive toxicity studies in animals and human clinical data.
Good manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level.
EMA’s Guideline on good pharmacovigilance practices (GVP) - Product- or Population-Specific Considerations III: Pregnant and breastfeeding women lists key periods of embryo-foetal susceptibility and a pregnancy classification based on duration that can be used for protocol development.
8 paź 2003 · Part IV - GMP requirements for Advanced Therapy Medicinal Products. Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products; Other documents related to GMP and GDP. Compilation of Union Procedures on Inspections and Exchange of Information
21 lut 2022 · 1 min read. Eudralex Volume 4 - EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. 21 FEBRUARY 2022. vol4_annex21_en.pdf. English. (451.32 KB - PDF) Download. Details. Publication date. 21 February 2022. Author. Directorate-General for Health and Food Safety. Share this page.
The European Medicines Agency's (EMA) provides answers to frequently asked questions on good manufacturing practice (GMP) and good distribution practice (GDP), as discussed and agreed by the GMP/GDP Inspectors Working Group.
