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.
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 information accessibility.
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 public health. Whether you’re a domestic food manufacturer or an importer, understanding and meeting these requirements is critical for market success.
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 appropriate for consumers.
MHRA’s Decentralised Manufacture Designation – Regulatory Framework
An overview of designation criteria, submission steps, and compliance considerations for POC and modular manufacturing