Finalized Guidance on Parallel MAA, EU-M4all procedure -EMA

The European Medicines Agency (EMA) on 22 April 2021 released the final version of its guidance for parallel EU-M4all (Article 58) and centralized marketing authorization applications (MAAs).

Article 58 procedure allows EMA’s CHMP to give opinions in cooperation with the WHO on medicines planned to be used in low- and middle-income countries outside the EU to address public health priorities. Example: HIV/AIDS, malaria Vaccines & Medicines.

So far, the pathway has been used to obtain opinions for 11 products, five of which have been withdrawn for commercial reasons or due to changes in treatment guidelines.

The guidance now notes that WHO experts and experts/observers from target countries will act as scientific expert reviewers to the EU rapporteurs’ assessment reports (ARs) and provide expertise and input as they would for the standalone EU-M4all procedure.