News & Updates

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...

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.

Your genes provide the instructions for making proteins, and many of these proteins are involved in how your body handles and responds to medicines. Genetic differences (variations) can lead to differences in these proteins, which in turn affect your response to a drug.

This document, published by the European Medicines Agency (EMA) in 2015, provides comprehensive regulatory guidance for the pharmaceutical industry and national competent authorities on minimizing and preventing medication errors throughout a medicinal product's life-cycle.

This document is a Direct Healthcare Professional Communication (DHPC) issued in August 2025 by a Marketing Authorization Holder (MAH) in agreement with the Egyptian Drug Authority. Its primary purpose is to communicate a critical safety warning regarding the use of the diabetes medication Metformin in patients with specific mitochondrial diseases.

This document is an official guideline from the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA). It provides a comprehensive framework for the management of safety signals for human medicines authorised in the European Union (EU).