Snapshot

The EU-M4all (formerly Article 58) - Accelerated Assessment pathway has been developed by the of EU-EMA.

This pathway can be used where Medicines of a major interest for public health and in particular from the viewpoint of therapeutic innovation (unmet medical need)..

This pathway facilitates activities during development.

It is an abridged review (a reliance pathway).

Medicinal products targeting an unmet medical need or which are of major public health interest in the intended markets outside the European Union can benefit from mechanisms to accelerate the registration process or adapt the development and the scientific requirements to the particularities of the disease. Accelerated assessment reduces the timeframe for review of an Article 58 application for medicinal products of major public health interest and in particular from the viewpoint of therapeutic innovation. 6-7 months before submission of an Article 58 application, applicants must notify EMA of their intention to request accelerated assessment. 2-3 months before submission, applicants must request accelerated assessment. Accelerated assessment reduces assessment time for Article 58 applications to 150 days or less (compared to standard 210 days).