Snapshot

The EU-M4all (formerly Article 58) - Conditional Article 58 scientific opinion pathway has been developed by the of EU-EMA.

This pathway can be used where Medicines for seriously debilitating or life-threatening diseases; emergency situations; or orphan medicinal products. The products must fulfill these criteria: positive risk-benefit balance; applicant likely to be able to provide comprehensive data after adoption of the scientific opinion; fulfills unmet medical need; and benefits of immediate availability outweigh the risks due to additional data still being required..

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. Conditional Article 58 scientific opinion allows the Committee for Medicinal Products for Human Use (CHMP), for certain medicinal products fulfilling an unmet medical need and in view of their positive risk-benefit balance, to provide a recommendation on use before comprehensive clinical data are available.