Snapshot

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

This pathway can be used where Medicines without comprehensive data on efficacy and safety under normal conditions of use, respectively because: • indications encountered so rarely that the applicant cannot reasonably be expected to provide comprehensive evidence; • in the present state of scientific knowledge, comprehensive information cannot be provided, or it would be contrary to generally accepted principles of medical ethics to collect such information..

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. Article 58 scientific opinion under exceptional circumstances allows the CHMP to evaluate medicinal products in specific diseases where comprehensive data could not be generated.