EMA Announces Reorganization

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 08-03-2016 08:50


The European Medicines Agency (EMA) has announced some organizational adjustments and important strategic amendments of its corporate management structure that the agency says will result in a leaner, more streamlined architecture and improved administrative support. Building on the 2013/2014 reorganization of the agency, the changes fine-tune the re-engineered organizational model to further improve efficiency and effectiveness of EMA’s operations. All changes will come into effect on September 1, 2016.

The main changes include: (1) reduction of the number of divisions dealing with human medicines from four to three, with one division responsible for support to medicines developers, one for the evaluation of medicines bringing scientific and procedure management under one umbrella, and one for the oversight of medicines, including pharmacovigilance and inspections; (2) creation of a new function dedicated to strengthening the collaboration between the EMA and the national competent authorities by overseeing the implementation of the joint network strategy to 2020, promoting innovation in regulatory science across the European regulatory system for medicines, and addressing the increasing complexity of the committees’ activities coordination; and (3) streamlining the division dealing with administration and corporate management through separate entities for strategic planning, budgeting and monitoring, finance and procurement, and support to staff and delegates.

Interactions between stakeholders and the agency will not be affected by these changes.

Source: European Medicines Agency


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