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

Regulatory NewsRegulatory News | 28 April 2015 |  By 

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.

EMA Clarification

The practice of post-market drug monitoring, also known as pharmacovigilance, is an important part of ensuring patient safety after a product has been approved. By monitoring drugs and collecting reports of suspected adverse drug reactions (ADRs), companies, regulators and healthcare providers can continue to assess a product's safety using real world data.

It is important for regulators that companies continue these activities even for donated products that treat neglected conditions, as ADRs help regulators determine the safety profile of a drug.

According to EMA, Marketing Authorisation Holders (MAHs) in the EU are required to report "all suspected adverse reactions (ADRs) occurring in the EU or in third countries which are brought to their attention."

This also holds true for donated products, as this data is relevant to the overall safety profile of a product.

MAHs are also required to submit serious suspected ADRs from outside the EU to the EU's pharmacovigilance database, EudraVigilance. Non-serious ADRs should still be reported, but may be done in a tabulated summary and submitted regularly to the appropriate authorities.




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