Europe – EMA finalizes guidance on parallel MAA, EU-M4all procedure

The European Medicines Agency (EMA) on Thursday released the final version of its guidance detailing the agency’s procedure for parallel EU-M4all (Article 58) and centralized marketing authorization applications (MAAs).
The guidance was adopted earlier this month following a public consultation launched in January and includes some minor changes from the draft version. (RELATED: EMA offers parallel Article 58, centralized authorization reviewsRegulatory Focus 14 January 2021).
The EU-M4all procedure allows EMA’s Committee for Medicinal Products for Human Use (CHMP) to issue opinions on cooperation with the World Health Organization (WHO) on medicines intended for use in low- and middle-income countries outside the EU to address public health priorities.
So far, the pathway has been used to obtain opinions for 11 products, five of which have been withdrawn for commercial reasons or due to changes in treatment guidelines. EMA says the opinions have led to 138 approvals in 90 non-EU countries as of July 2020