Category: Regulatory

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 Health Canada has now issued a revised draft guidance to provide Information and Submission Requirements of Biosimilar Biologic Drugs (June 2025).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

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 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

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 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.