CADIFA Manual for Administrative Procedures:
The updated CADIFA Manual for Administrative Procedures by ANVISA was published in February 2025 and is available in Portuguese and English on the agency’s website.
Guideline on Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQ)
What is ADE FUQ?
The Adverse Drug Event Follow-Up Questionnaire (ADE FUQ) is designed to provide guidance to the EU/EEA regulatory medicines network on the appropriate use of Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQs) in routine pharmacovigilance activities, as outlined in the Good Pharmacovigilance Practices (GVP) module V, V.B.6.1.1.
EMA Seeks Feedback on Approaches to Qualifying Novel, Non-Mutagenic Impurities – Europe
The European Medicines Agency (EMA) has started a discussion about how to qualify novel impurities based on principles and methods.
The implementation of the ICH GCP guideline is scheduled for July by EMA.
The International Council for Harmonization guidelines on Good Clinical Practices will be brought into effect by the European Medicines Agency on July 23, 2025.
AU-TGA eCTD Submission Updates:
TGA has announced updates to Module 1 & Regional Information to the specifications and technical validation criteria transitioning from eCTD AU Module-1 v3.1 to v3.2.
