EU Medicines Agencies: Strategy for the next five Years

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have published a draft paper for consultation on the EU Medicines Agencies' Network Strategy to 2020. This document describes the envisaged strategy for the regulators' network for the next 5 years. For the first time now, a single strategy paper of both agencies will be published. With this common strategy, they want to foster "a coordinated approach to address the multiple challenges and opportunities that face the network". As stated in the document, it doesn't describe necessary actions to be taken or work to be done but defines a "high level strategy, explaining what needs to be taken forward and why." Following this paper, so called multi-annual work plans for both EMA and HMA as well as for CMD (human and veterinary) will be issued to give detailed information on the work of each component of the network.

One major goal is to "optimise the operation of the network and the need to act and collaborate globally" by strengthening communication and links within the network and with other authorities and stakeholders.

Another goal is "Contributing to the global regulatory environment" with the objective to "ensure best use of resources through promoting mutual reliance and work-sharing". This could also be achieved by further exploring supplier inspection databases and the trade deals like TTIP, CETA and free trade agreements with Japan and Singapore. Those could provide a way of promoting EU GMP (and GDP) standards globally.

Other goals are:

• Contributing to human health with ensuring the availability of medicines
• Contributing to animal health and human health in relation to veterinary medicines