News & Updates

This document is the Report of the CIOMS Working Group XIV on Artificial Intelligence in Pharmacovigilance. It addresses the rapidly emerging and cross-disciplinary field of integrating Artificial Intelligence (AI) into Pharmacovigilance (PV).

This document is the official strategy published by the World Health Organization (WHO) to provide a practical and adaptable framework for countries, particularly Low- and Middle-Income Countries (LMICs), to build, strengthen, and sustain their Pharmacovigilance (PV) systems for medicines and vaccines.

This document is the official strategy published by the World Health Organization (WHO) to guide countries on how to harness the potential of traditional, complementary, and integrative medicine (TCIM) over the next decade (2025-2034). It serves as a global framework for governments, partners, and stakeholders to integrate safe, effective, and evidence-based TCIM into their national...

This document is the official Egyptian guideline for the Medical Device Vigilance System. Issued by the Egyptian Drug Authority (EDA), it establishes the mandatory framework for monitoring the safety and performance of medical devices after they have been approved and are being used in the Egyptian market. Its primary goal is to protect patient and user health by...

This document is the Draft Guideline for Veterinary Good Pharmacovigilance Practices in Egypt (VGVP). It is a comprehensive regulatory framework issued by the Egyptian Drug Authority (EDA), specifically through its Central Administration for Pharmaceutical Care and General Administration for Pharmaceutical Vigilance.

Here is a detailed explanation of the WHO guideline "Recommendations on care for women with diabetes during pregnancy" in English, covering its titles and key details.

This document, "Guidance on the format of the risk management plan (RMP) in the EU – in integrated format" (EMA/164014/2018 Rev.2.0.1), is an official guideline from the European Medicines Agency (EMA). It provides a standardized template and detailed instructions for pharmaceutical companies (Marketing Authorisation Applicants/Holders) on how to create, structure, and update a Risk...