RAPS: EMA Says Companies Still Need to Report Side Effects of Donated Drugs

Drug makers are frequently involved in relief and humanitarian aid efforts, often through donating their products. However, in light of recent outbreaks of neglected tropical diseases such as Ebola, the World Health Organization (WHO) has asked the European Medicines Agency (EMA) to clarify its drug safety monitoring requirements for companies that donate medicines outside the EU to treat neglected tropical diseases. According to WHO, neglected tropical diseases are a group of \"medically diverse\" diseases (virus, bacteria, parasite) that impact more than 1 billion people. These diseases are said to be \"neglected\" because they affect people in low resource settings, making it difficult for companies to see a return on their investment developing treatments for these conditions.