Malaria sickens roughly 200 million people each year and kills more than 600,000, most in sub-Saharan Africa. Yet the initial regulatory review of the first vaccine to prevent malaria, RTS,S, will occur on another continent, where the disease is all but nonexistent: On 24 July, the British drug giant GlaxoSmithKline announced that it had filed an application with the European Medicines Agency (EMA) under Article 58. A little-known provision of a 2004 EU regulation, Article 58 allows the agency to give a scientific opinion on medicines intended exclusively for markets outside Europe to speed access to new drugs and assist countries that may not have the capacity to do their own regulatory reviews.
The Article 58 procedure doesn't lead to an approval, and a positive decision from the EMA wouldn't give GlaxoSmithKline any authority from the agency to market RTS,S in Africa or elsewhere. But it would provide countries that are considering approving the vaccine some assurance of its safety and efficacy. It would also help secure (though not guarantee) RTS,S a spot on the World Health Organization's list of prequalified vaccines and medicines, those that the institution has deemed safe, efficacious and of high quality.
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