Kuwait Ministry of Health Marks Significant Advancement in Pharmaceutical Regulatory Digitalization
The Kuwait Ministry of Health (Kuwait MOH) has made an important leap forward in the pharmaceutical regulatory landscape by transitioning from the Common Technical Document (CTD) format to the Electronic Common Technical Document (eCTD). This move aims to streamline the submission process for new drug applications, enhancing efficiency and ensuring compliance with international standards.
Understanding the Structured Product Monograph (SPM) for Health Canada Submissions
The Structured Product Monograph is submitted to Health Canada when you are seeking approval to market a new drug or health product in Canada. Health Canada reviews the SPM to ensure the product is compliant with the Food and Drugs Act and related regulations. It’s an important part of the New Drug Submission (NDS) or Natural Health Product Submission (NHP) process.
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.