GVP Module VI Addendum II: Masking Personal Data in ICSRs – A Vital Step Toward Privacy Pharmacovigilance plays a crucial role in safeguarding public health. However, as data flows through systems like EudraVigilance, protecting personal data becomes equally essential.
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What is Aggregate Reporting
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.
What is Computer System Validation (CSV)
In today’s fast-evolving digital landscape, businesses increasingly rely on complex computer systems to manage critical operations, especially in regulated sectors like pharmaceuticals, biotechnology, medical devices, and manufacturing.
What is Regulatory Artwork
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
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
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)