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 that certain CEP applications are being submitted under the sister file procedure even though their characteristics would more appropriately classify them as new applications.
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 something called an Investigational Device Exemption, or IDE, from the FDA.
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 events.
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).