Europe – EMA offers parallel Article 58, centralized authorization reviews

The European Medicines Agency (EMA) on Thursday issued a draft guidance for consultation explaining how sponsors can pursue a parallel Article 58 (EU-M4all) opinion and centralized marketing authorization for medicines they intend to market in the EU and abroad.

The Article 58 procedure allows EMA’s Committee for Medicinal Products for Human Use (CHMP) to give opinions in cooperation with the World Health Organization (WHO) on medicines intended to be used in low- and middle-income countries outside the EU to address public health priorities. Examples of eligible products include vaccines and medicines to treat HIV/AIDS, malaria and tuberculosis.

So far, Article 58 has only been used to obtain opinions for 11 products, five of which have since been withdrawn for commercial reasons or due to changes to treatment guidelines. EMA says the procedure has led to 138 approvals in 90 non-EU countries as of July 2020. More than half of those approvals were for AbbVie’s HIV treatment Aluvia (lopinavir/ritonavir), which has been registered in more than 70 countries using the scientific opinion generated via the Article 58 procedure. The most recent product to receive an Article 58 opinion is the International Partnership for Microbicides’ Dapivirine Ring (dapivirine), which is intended to reduce the risk of HIV-1 infection via vaginal intercourse in women 18 and older…