Snapshot

The EU-M4all (formerly Article 58) - Standard Procedure pathway has been developed by the European Medicines Agency of EU-EMA.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Regional regulatory initiatives can help optimize the efficient use of an agency’s resources. The following countries participate in this initiative/pathway: EU-EMA

Scientific evaluation: Up to 210 active days of assessment; The CHMP evaluates the application with input from WHO experts and observers from target countries, as needed. The PRAC provides input on aspects related to risk management. The CHMP may also request inspections of sites used for clinical trials and manufacturing or of pharmacovigilance systems. NB: The pre-submission requirements and evaluation procedure are similar to the centralised marketing authorisation procedure.