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.
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.
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.
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
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 |