Category: Regulatory

What Is Drug Master File (DMF) Submission? Drug Master File (DMF) submission is a classified document that is submitted to the U.S. Food and Drug Administration (FDA) and entails detailed data regarding the manufacturing, processing, packaging or storage of the components employed in the pharmaceutical drug products.

Aggregate Reporting in Pharmacovigilance: A Critical Compliance Requirement A legal and ethical duty of pharmaceutical companies is safety monitoring of their products during the lifecycle; the drug development and post-marketing. As Individual Case Safety Reports (ICSRs) only involve recording individual adverse events, the focus is received on a bigger picture with aggregate reporting.

Regulatory artwork is crucial in the highly regulated industry of product manufacturing and distribution, and this is relevant especially in making the products comply with the legal requirements and make them available to consumers in time.

Implementation of The European Pharmacopoeia Supplement 12.1 Publication schedule:   Issue Publication date Correction date Implementation date 12.1 07/2025 31/08/2025 01/01/2026 12.2 10/2025 30/11/2025 01/04/2026 12.3 01/2026 28/02/2026 01/07/2026

In today’s global marketplace, regulatory labeling is vital for product compliance, consumer safety, and corporate success. Regulatory labeling refers to the necessary information that manufacturers must show on their products or packaging in order to meet legal requirements established by government authorities and international organizations.

What is GDUFA? Understanding the Generic Drug User Fee Act The pharm industry is a well-regulated sector, where innovation, safety, and accessibility have to be balanced. The Generic Drug User Fee Act (GDUFA) is one of the significant acts in the United States that can influence the process of reviewing and approving generic drugs.

Navigating Biosimilar Biologic Drug Submissions in Canada: A Strategic Guide Biosimilars are transforming the contemporary pharmaceutical landscape as the need to find affordable treatment options increases. Health Canada has now issued a revised draft guidance to provide Information and Submission Requirements of Biosimilar Biologic Drugs (June 2025). This elaborated framework solidifies the dedication of Canada… Continue reading Navigating Biosimilar Biologic Drug Submissions in Canada: A Strategic Guide

The Egyptian Drug Authority begins today to activate the electronic payment service through its official website The Egyptian Drug Authority announced the start of activating the electronic payment service through the official website of the Authority, as part of its continuous efforts towards digital transformation and enhancing the efficiency of the services provided, which contributes… Continue reading The Egyptian Drug Authority begins today to activate the electronic payment service through its official website

Egypt Joins EDQM’s OMCL Network as an Associated Member: A Leap Forward for Global Medicines Quality Control Masuu Global is proud to highlight a significant milestone in international pharmaceutical collaboration: The BIO INN Laboratories of the Egyptian Drug Authority (EDA) have joined the General European OMCL Network (GEON), co-ordinated by the European Directorate for the Quality of Medicines &… Continue reading Egypt Joins EDQM’S OMCL Network as an Associated Member

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