EMA Updates Adverse Event Reporting Requirements for Neglected Tropical Diseases

Monday, May 4, 2015

Source: FDA News

Drugmakers in Europe must record and report serious suspected adverse events that are brought to their attention concerning drugs they donate outside the EU to treat neglected tropical diseases.

The European Medicines Agency issued the clarification last week after receiving a request from the World Health Organization.

Serious suspected adverse reactions should be reported to EU competent authorities as individual case safety reports by means of the EudraVigilance database. Nonserious adverse events can be reported by means of summary tabulations and discussion in periodic safety update reports, the agency says.

Industry will be relieved by this clarification because it’s impossible to report all suspected adverse events when tens of millions of people are being treated, Eric Ottensen, director of the Neglected Tropical Diseases Support Center at the Task Force for Global Health, said.

WHO has prioritized 17 NTDs — including leprosy, dengue fever and schistosomiasis — that are endemic in 149 countries and affect more than 1.4 billion people.

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