Streamlining Change: New EU Guidelines Simplify Medicines Lifecycle Management EMA welcomes the publication of the European Commission’s (EC) new Variations Guidelines, which streamline the lifecycle management of medicines (see EC news). These EU Variation guidelines will support the implementation of the new Variations Regulation that came into force in 15 January 2025.
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What is a Stability Study
What is a Stability Study? A stability study is the evaluation of the ability of a pharmaceutical product to remain in its quality, safety and efficacy over a period under designated environmental conditions. It is critical in the establishment of shelf life, packaging, and storage rules. The regulatory bodies demand stability data so that medicines… Continue reading What is a Stability Study
What is an Audit Trail
What is an Audit Trail? The accuracy, integrity and traceability of data is non-negotiable in the pharmaceutical industry. All data created in the process of drug development, manufacturing, testing, and distribution should be dependable and inaccessible.
Changes to e-Submission Requirements for CEP Applications
Changes to e-Submission Requirements for CEP Applications As part of continuous digital transformation in regulatory processes, the European Directorate for the Quality of Medicines & HealthCare (EDQM) has introduced automation to enhance the management and review of Certificates of Suitability to the Monographs of the European Pharmacopoeia (CEP) submissions.
What is Batch Record Review
What is Batch Record Review? Product quality and regulation standards are of paramount importance in the pharmaceutical manufacturing process. The Batch Record Review (BRR) is one of the most vital aspects that guarantee this compliance. It is a documented verification procedure that either validates or disapproves a drug product upon release that has been produced… Continue reading What is Batch Record Review
What is Clinical Regulatory Writing
What is Clinical Regulatory Writing? Clinical Regulatory Writing is a highly specialized type of medical writing which facilitates the development, approval and post marketing surveillance of drugs and medical devices. It includes developing the necessary materials needed by international health regulators, including the FDA, EMA, and MHRA, when performing the clinical trial and regulatory submission… Continue reading What is Clinical Regulatory Writing
What is Qualified Person (QP)
What is Qualified Person (QP)? The Qualified Person (QP) is very important in pharmaceutical manufacturing as it ensures that medicinal products adhere to all required quality and regulatory specifications before being released in the market. Pharmaceutical regulations in most countries and especially in the European Union require this role and it is essential to the… Continue reading What is Qualified Person (QP)
What is a Drug Regulatory Authority
What is a Drug Regulatory Authority? In the pharmaceutical sector, integrity of drug development, production, and distribution matters most. The main role of Drug Regulatory Authority (DRA) is to ensure that the pharmaceutical product is of the set standard of safety, quality and efficacy.
What is Claim Substantiation
What is Claim Substantiation? Claim substantiation in pharmaceutical business is a very important process whereby all claims that are related to products such as therapeutic, preventive and supportive ones are supported by reliable scientific facts. The practice is not only a regulatory liability but also a pillar of an ethical marketing practice and patient safety.
What is Clinical Regulatory Writing
What is Clinical Regulatory Writing? Clinical Regulatory Writing is a highly specialized type of medical writing which facilitates the development, approval and post marketing surveillance of drugs and medical devices. It includes developing the necessary materials needed by international health regulators, including the FDA, EMA, and MHRA, when performing the clinical trial and regulatory submission… Continue reading What is Clinical Regulatory Writing