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… Continue reading Kuwait Ministry of Health Marks Significant Advancement in Pharmaceutical Regulatory Digitalization
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Understanding the Structured Product Monograph (SPM) for Health Canada Submissions
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… Continue reading Understanding the Structured Product Monograph (SPM) for Health Canada Submissions
CADIFA Manual for Administrative Procedures – MANUAL-F-ANVISA-011 v.01
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)
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… Continue reading Guideline on Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQ)
EMA Seeks Feedback on Approaches to Qualifying Novel, Non-Mutagenic Impurities – Europe
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 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
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.
How AI Will Help the Pharmaceutical Industry
How AI Will Help the Pharmaceutical Industry: The pharmaceutical industry is one of the most complex and regulated sectors in the world. However, with the rise of artificial intelligence (AI), there’s an incredible opportunity to accelerate processes, lower costs, and ultimately improve patient outcomes. AI is transforming various aspects of the pharmaceutical sector, from drug… Continue reading How AI Will Help the Pharmaceutical Industry
Understanding Periodic Safety Update Reports (PSURs) and Their Importance in Pharmacovigilance
Understanding Periodic Safety Update Reports (PSURs) and Their Importance in Pharmacovigilance In the world of pharmaceutical regulation, ensuring the ongoing safety of medicinal products post-market approval is just as crucial as during their development. One of the most important documents used to monitor and evaluate the safety of a drug after it hits the market… Continue reading Understanding Periodic Safety Update Reports (PSURs) and Their Importance in Pharmacovigilance
Artwork Divisions in Pharmaceutical Packaging
Artwork Divisions in Pharmaceutical Packaging The pharmaceutical packaging industry is complex, highly regulated, and essential to ensuring the safety and efficacy of products. Artwork divisions are a fundamental part of this process, providing the expertise needed to create packaging that is both compliant and effective. From navigating intricate regulatory requirements to understanding the nuances of… Continue reading Artwork Divisions in Pharmaceutical Packaging