Category: Regulatory

Clarification on the Use of the Sister File Procedure-EDQM The current EDQM policy PA/PH/CEP (09) 141, 2R, “Guidance on applications for “sister files”, has guided the sister file procedure for CEPs for many years. Experience gathered over time indicates that there may be discrepancies in the understanding of the procedure and the EDQM has noted… Continue reading Clarification on the Use of the Sister File Procedure-EDQM

IMPLEMENTATION OF THE EUROPEAN PHARMACOPOEIA SUPPLEMENT 12.3 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 13.1 04/2026 31/05/2026 01/01/2027 13.2 07/2026 31/08/2026 01/04/2027  

What Is an Investigational Device Exemption (IDE)? Enabling Clinical Trials for Medical Devices in the U.S. If you intend to sell a medical device in the United States, it is necessary to prove it is safe and operates as intended. Before doctors can test a new device on people, the company behind it usually needs… Continue reading What Is an Investigational Device Exemption (IDE)?

What Is an Individual Case Safety Report (ICSR)? A Key Component of Pharmacovigilance Pharmacovigilance plays a vital role in overseeing the safety of medicinal products during the lifecycle of the products. The Individual Case Safety Report (ICSR) is considered to be one of the most significant tools that are employed to monitor and analyze adverse… Continue reading What Is an ICSR

What Is an IMPD? Understanding the Investigational Medicinal Product Dossier Regulatory approval is a pre-requisite prior to initiating any clinical trial that involves any medicinal products in the European Union. Among the most significant papers needed in this procedure is Investigational Medicinal Product Dossier (IMPD).

CE Medical Device Regulatory Affairs: Ensuring Compliance and Market Access in Europe The CE marking is one of the mandatory requirements of medical devices that are sold in the European Union. It implies that a medical device is in compliance with the relevant regulatory requirements of safety, performance, and quality. CE medical device regulatory affairs… Continue reading CE Medical Device Regulatory Affairs: Ensuring Compliance and Market Access in Europe

USFDA ESG NextGen Update: FAERS Submission Type Removal USFDA ESG NextGen Update: The U.S. Food and Drug Administration (FDA) is developing its regulatory submission systems under the Electronic Submission Gateway NextGen (ESG NextGen) system. There was a significant change that has been made regarding the FDA Adverse Event Reporting System (FAERS) recently. Some forms of… Continue reading USFDA ESG NextGen Update: FAERS Submission Type Removal

Understanding Regulatory Affairs in Life Sciences Regulatory affairs play a critical role in ensuring that biotechnology and pharmaceutical products are safe, effective, and compliant with global health authority requirements. From early research to post-market surveillance, regulatory professionals act as a bridge between scientific innovation and regulatory compliance, enabling products to reach patients responsibly and efficiently.

FDA 21 CFR Part 11 Compliance Checklist: A Practical Guide Regulation 21 CFR Part 11 FDA lays down the requirements according to which the electronic records and electronic signatures should be regarded as credible, dependable, and identical to the paper records and handwritten signatures. Part 11 compliance is mandatory in those life sciences organizations that… Continue reading FDA 21 CFR Part 11 Compliance Checklist: A Practical Guide