Effective Preparation for Pharmacovigilance Inspections: Key Steps for MAHs Pharmacovigilance (PV) inspections are a crucial part of ensuring public health safety within the European Union (EU). These inspections are conducted by national competent authorities in cooperation with the European Medicines Agency (EMA) to verify that marketing authorisation holders (MAHs) are meeting their pharmacovigilance obligations.
Author: masuuglobal
Health Canada’s Mandatory XML Product Monograph Rule Takes Effect July 18, 2025
Health Canada’s Mandatory XML Product Monograph Rule Takes Effect July 18, 2025 Change in Filing Requirements for XML PM? Health Canada is making Structured Product Monograph (SPM) submissions in XML format mandatory starting July 18, 2025, for select drug applications. This move is part of Canada’s broader effort to modernize regulatory submissions and improve drug… Continue reading Health Canada’s Mandatory XML Product Monograph Rule Takes Effect July 18, 2025
USFDA Food Compliance 101: Key Requirements for Manufacturers and Importers
USFDA Food Compliance 101: Key Requirements for Manufacturers and Importers When it comes to selling or distributing food products in the United States, compliance with the regulatory requirements of the U.S. Food and Drug Administration (USFDA) is essential. The FDA is responsible for ensuring the safety, labeling accuracy, and quality of food products to protect… Continue reading USFDA Food Compliance 101: Key Requirements for Manufacturers and Importers
Complying with Canadian Food Safety and Labeling Standards: A Regulatory Overview
Complying with Canadian Food Safety and Labeling Standards: A Regulatory Overview For businesses involved in the marketing or distribution of food in Canada, businesses must comply with the regulatory framework set by Health Canada and the Canadian Food Inspection Agency (CFIA). These regulations ensure that food sold in Canada is safe, properly labeled, and nutritionally… Continue reading Complying with Canadian Food Safety and Labeling Standards: A Regulatory Overview
MHRA’s Decentralised Manufacture Designation – Regulatory Framework
MHRA’s Decentralised Manufacture Designation – Regulatory Framework An overview of designation criteria, submission steps, and compliance considerations for POC and modular manufacturing
Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials : EMA Initiates Consultation on New Clinical Trial Guidance
Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials : EMA Initiates Consultation on New Clinical Trial Guidance The European Medicines Agency (EMA) invites public feedback on a new draft guideline focused on including pregnant and breastfeeding populations in clinical trials, addressing critical gaps in medicine safety and efficacy data. The consultation is open until… Continue reading Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials : EMA Initiates Consultation on New Clinical Trial Guidance
AI-Powered Pharmacovigilance: The Future of Drug Safety Surveillance
AI-Powered Pharmacovigilance: The Future of Drug Safety Surveillance Artificial Intelligence (AI) refers to the simulation of human intelligence in machines, enabling them to perform tasks such as learning, reasoning, and problem-solving. In healthcare, AI has already shown significant promise in areas like diagnosis, treatment planning, and personalized medicine, transforming patient care delivery.
Overview of FDA Covered Product Authorization (CPA) and the CREATES Act
Overview of FDA Covered Product Authorization (CPA) and the CREATES Act What is FDA Covered Product Authorization (CPA)? FDA Covered Product Authorization refers to the official approval given by the U.S. Food and Drug Administration (FDA) for certain medical products to be marketed in the United States.
Health Canada Validation Criteria 5.3 – Compliance Update Effective May 31, 2025
Health Canada Validation Criteria 5.3 – Compliance Update Effective May 31, 2025 As part of our continued commitment to regulatory compliance and operational excellence, we are notifying our clients, partners, and stakeholders about important updates to Health Canada’s Validation Criteria, version 5.3, which will come into effect on May 31, 2025.
Swissmedic Nitrosamine Risk Assessment Requirements
Swissmedic Nitrosamine Risk Assessment Requirements Swiss agency updated the guidance on nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents.