Guideline for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and Biological Products Artificial Intelligence (AI) is rapidly transforming various industries, including the pharmaceutical sector. Regulatory authorities are increasingly exploring AI-driven tools to enhance decision-making processes related to drug and biological product approvals. However, the integration of AI in regulatory science… Continue reading Guideline for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products
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CARES Act Section 505G: Modernizing OTC Drug Monographs
CARES Act Section 505G: Modernizing OTC Drug Monographs The CARES Act, signed into law on March 27, 2020, brought significant changes to the regulatory framework governing Over-the-Counter (OTC) drugs in the U.S. Section 505G, which was added to the Federal Food, Drug, and Cosmetic (FD&C) Act, specifically addresses OTC monograph drugs and aims to modernize… Continue reading CARES Act Section 505G: Modernizing OTC Drug Monographs
Pharmacovigilance System Master File (PSMF): Its Importance and Regulatory Role in Ensuring Drug Safety
Pharmacovigilance System Master File (PSMF): Its Importance and Regulatory Role in Ensuring Drug Safety The Pharmacovigilance System Master File (PSMF) is a key regulatory requirement under the EU pharmacovigilance legislation, ensuring that medicinal products authorized in the European Union (EU) comply with the stringent safety monitoring and reporting standards. Its primary objective is to provide… Continue reading Pharmacovigilance System Master File (PSMF): Its Importance and Regulatory Role in Ensuring Drug Safety
FDA Modernizes the Electronic Submission Gateway (ESG) with ESG NextGen
FDA Modernizes the Electronic Submission Gateway (ESG) with ESG NextGen The FDA is launching ESG NextGen, a modern, cloud-based system designed to improve the submission process. Key features include a unified submission portal, real-time tracking, enhanced cybersecurity, and API integration. This modernization expands bandwidth and storage capacity, allowing for a more seamless and efficient experience.
Kuwait Ministry of Health Marks Significant Advancement in Pharmaceutical Regulatory Digitalization
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
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.
