This means that the network, composed of the European Commission, EMA and the 30 national authorities of the European Economic Area Member States, are recognised as meeting international regulatory standards, guidelines and practices.

Emer Cooke, EMA’s Executive Director, said: “I am delighted that the European Union (EU) medicines network has now been officially recognised by WHO as a global reference authority, operating at the highest regulatory standards. This acknowledgement provides a formal basis for the important work that EMA and the EU are already doing to promote reliance practices globally. We will continue our commitment to ensuring that available medicines are safe, effective, and of high quality and look forward to our work with WHO and other regulatory authorities around the world to improve global public health.”

Sandra Gallina, European Commission Director General for Health and Food Safety, said: “Today’s recognition of the European Medicines Regulatory Network as a WHO Listed Authority is a very positive step forward. The fact that it is the first Regional Regulatory System to be listed as a WLA shows the confidence placed in this Network and the value of the work we do for public health. I welcome this recognition and commend the excellent cooperation between the Commission, EMA and EU Member States which has allowed us to reach this milestone.”

The assessment process was facilitated by the Steering Group for Benchmarking of European Medicines Agencies (BEMA SG).

Prof. Rui Santos Ivo, PhD, President of the Portuguese Authority of Medicines and Health Products (INFARMED) and BEMA SG co-chair, said: “This milestone underscores our commitment to regulatory excellence and international collaboration in safeguarding public health. It is also a confirmation that the EU remains steadfast in the pursuit of innovation and continuous improvement to ensure the availability, as well as safe and effective medicines for patients."

Prof. Siniša Tomić, PhD, Head of the Agency for Medicines and Medical Devices in Croatia (HALMED), and the BEMA SG’s other co-chair continued: “The contributions of the national competent authorities to the self-assessment process signify our joint commitment to global regulatory transparency and accountability. The WLA listing reaffirms the dedication of the whole regulatory network to ensuring the consistent standards of quality, safety and efficacy of medicinal products, prioritizing patient safety and access to quality healthcare across the EU and beyond."

The EMRN is the cornerstone of EMA’s work and success. The Agency operates at the heart of the network, coordinating and supporting interactions of national competent authorities for human and veterinary medicines in Europe. The designation as WLA follows a comprehensive assessment by WHO. It covers each individual regulatory authority of the EMRN, as well as the EMRN overall, which is recognised as a single entity and has also been designated as a ‘regional regulatory system’.

Collaboration with WHO is specifically highlighted in the legislation establishing EMA. The WLA designation complements the cooperation between these organisations in the context of global public health networks and initiatives.

WHO Listed Authority initiative

A WLA is a regulatory authority or a regional regulatory system which has been judged to comply with all the indicators and requirements specified by WHO. The WLA initiative is being implemented by WHO to promote access to and supply of safe, effective, and high quality medical products. It ensures optimal use of limited global regulatory resources by facilitating reliance on the work and decisions of trusted regulatory authorities. The reliable and highly performing WLAs listed by WHO can be used as a reference point by regulatory authorities that lack the resources to perform all necessary regulatory functions, or which have not yet reached higher maturity levels for medical product oversight. Overall, the WHO Listed Authority framework is expected to promote confidence and reliance, whilst fostering regulatory convergence, harmonisation of approaches and international cooperation.

Note:

For a full list of WHO Listed authorities, see:

Share this page