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
Author: masuuglobal
What is Regulatory Labeling
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
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.
What is GMP Audit
Maintaining high standards for product safety and quality is a legal necessity for the food, pharmaceutical, cosmetic, and medical device industries. A good manufacturing practice audit, or GMP audit, is a comprehensive examination procedure intended to make sure that a business’s production procedures comply with global regulatory requirements.
Navigating Biosimilar Biologic Drug Submissions in Canada: A Strategic Guide
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 Health Canada has now issued a revised draft guidance to provide Information and Submission Requirements of Biosimilar Biologic Drugs (June 2025).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
EMA Launches Step 2 of eCTD v4.0 Technical Pilot for Centrally Authorised Products (CAP)
EMA Launches Step 2 of eCTD v4.0 Technical Pilot for Centrally Authorised Products (CAP) The European Medicines Agency (EMA) has officially launched Step 2 of the eCTD v4.0 Technical Pilot, focused on Centrally Authorised Products (CAP). This phase invites a limited number of Marketing Authorisation Holders (MAHs) to participate based on readiness and alignment with… Continue reading EMA Launches Step 2 of eCTD v4.0 Technical Pilot for Centrally Authorised Products (CAP)
An Analysis of GxP Audit Procedures and FDA Inspection Readiness Strategies
An Analysis of GxP Audit Procedures and FDA Inspection Readiness Strategies GxP audits are necessary in the pharmaceutical industry to ensure that operations comply with global regulatory standards, especially those established by the U.S. Understanding audit procedures and inspection readiness is essential for organizations involved in or supporting pharmaceutical manufacturing and R&D to ensure compliance… Continue reading An Analysis of GxP Audit Procedures and FDA Inspection Readiness Strategies
The Importance of GMP Audits in Ensuring Product Safety and Quality
The Importance of GMP Audits in Ensuring Product Safety and Quality Regardless of the industry, maintaining high standards of quality and assuring product safety is paramount to perform successfully, make profit and avoid mistakes. In the pharmaceutical sector protecting the patient’s safety and credibility requires performing Good Manufacturing Practices (GMP) audits. GMP custom made audits… Continue reading The Importance of GMP Audits in Ensuring Product Safety and Quality
The Egyptian Drug Authority begins today to activate the electronic payment service through its official website
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
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
