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 |
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.