Sixth strategic field of the of the EMA’s network strategy

The sustainability of the network and the responsible authorities is a key to success for both public health and Europe as a vigorous research location. To ensure this sustainability, there must be sufficient resources in financial and human dimensions in the form of competences and skills. This need is reflected in the five strategic objectives that the strategy paper identifies for this thematic area:

1. Building scientific and regulatory capabilities and capacities in the network;

2. Striving for operational excellence, building on the present strategy;

3. Achieving a financially sustainable model for the network;

4. Developing a digital strategy to guide the digital transformation;

5. Responding rapidly, adequately, and consistently to emerging threats to human-public and veterinary health.

A core element of sustainability is the optimization of existing processes. These will be aligned with the EU Commission's pharmaceutical strategy (we reported) and undergo an overall regulatory improvement. According to the strategy, this can particularly be achieved through division of labour between the different authorities as well as data standardization and exchange. In addition, bureaucratic hurdles are to be identified and reduced by a joint working group of HMA and EMA staff. Following on from the previous blog posts on the EMA's networking-strategy, sustainability also relates to the prior mentioned strategic areas, particularly the development and expansion of IT competencies and the necessary infrastructure.

In addition to building these competencies, there are other challenges mentioned in the action field of sustainability. Among others, these are:

• Implementing veterinary medicine and clinical trial regulations into this framework.

• Ensuring a successful funding model for the network, especially with regard to the recruitment of qualified personnel.

• Data consistency for medical and other relevant aspects.

In terms of the overall strategy, it becomes clear that all fields are interrelated and influence on another. Operationally, the 5-year strategy will be integrated into the daily work of the authorities and further developed there. A monitoring system is to be installed at EU level, which will publish a review after 18 months in which the status of the strategies' implementation will be presented.