The European Medicines Regulatory Network (EMRN) has been designated as WHO Listed Authority (WLA) by the World Health Organization (WHO). 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 operating at an advanced level of performance, meeting international regulatory standards, guidelines and practices.
The designation 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”.
Sandra Gallina, European Commission Director General for Health and Food Safety, said: “The 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.”
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.
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.
