The European Medicines Agency (EMA) issued a draft guidance yesterday (1/14) for medicines intended to be used in low- to middle-income countries outside the European Union (EU). The Article 58 process calls for EMA’s Committee for Medicinal Products for Human Use (CHMP) to work with the World Health Organization (WHO) to provide opinions on medicines like vaccines for malaria or tuberculosis. The draft guidance comes in light of interest from sponsors in receiving both an Article 58 opinion as well as a marketing authorization application (MAA), of which the EMA announced it will now evaluate applications in parallel.

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