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The Global Smart Pharmacovigilance Strategy

December 4, 2025

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.

WHO Global Traditional Medicine Strategy 2025–2034

November 30, 2025

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...

Egyptian guideline for the Medical Device Vigilance System

November 26, 2025

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...

Guidance on the format of the risk management plan (RMP) in the EU

November 10, 2025

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...

Guideline for Cosmetovigilance in the EU

October 24, 2025

Here is a detailed guideline for Cosmetovigilance, structured similarly to a pharmacovigilance guideline, but based on the core principles of EU Cosmetics Regulation (EC) No 1223/2009.

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