What is the Origin of EMA Centralised Procedure?

Established with the creation of the EMA, this procedure was designed to harmonize drug approval across the EU, replacing multiple national applications. The term 'centralised' denotes the single submission and evaluation process by the Committee for Medicinal Products for Human Use (CHMP). It is a critical mechanism for ensuring rapid, wide-scale access to new endocrine treatments.

What is the Mechanism of EMA Centralised Procedure?

A company submits a single application dossier containing comprehensive quality, non-clinical, and clinical data to the EMA. The CHMP conducts a scientific assessment, culminating in a recommendation for or against authorization. The European Commission then issues the final, legally binding decision, facilitating the simultaneous launch of complex hormonal medications, like advanced gonadotropin-releasing hormone agonists, throughout the region.

EMA Centralised Procedure ∞ Area

EMA Centralised Procedure

Meaning

The EMA Centralised Procedure is a regulatory pathway managed by the European Medicines Agency (EMA) that allows pharmaceutical companies to obtain a single marketing authorization valid across all European Union member states. Within the hormonal health domain, this is the standard route for approving novel hormone replacement therapies, selective receptor modulators, and endocrine-acting biologics. This streamlined process ensures a unified safety and efficacy standard across the European market.