Fimea’s strategy journey continued with the restructuring of its organisation

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The implementation of Fimea's strategy continued in 2021. The activities were steered and developed in accordance with the strategic objectives, and the strategy was put into practice and dismantled into sub-objectives, for example through personnel workshops. At the end of the year, an examination of the organisational structure was also launched with the aim of changing the structure to better support the implementation of the agency's strategy and respond to future challenges.

Fimea's operating environment is in in a constant state of change, due to factors such as the EU pharmaceutical strategy and health union, changes to the EMA mandate and numerous pieces of new legislation and new regulations concerning the sector. Changes in our operations are also brought about by the national reform and roadmap for pharmaceutical matters, the implementation of the client and patient safety strategy, the updating of pandemic plans and digitalisation. We want to be better and more flexible in responding to these changes in the operating environment by building an organisation that supports the active development of operations and competence.

The aim of the reform is also to balance the organisational structure and to re-optimise tasks to ensure smooth working, cooperation and functional entities and to safeguard the operational prerequisites of the agency in the future. It is also important to develop competence and strengthen cooperation and interaction both inhouse and with stakeholders.

Fimea's operations are divided into four areas of responsibility under which the activities are grouped:

  • Marketing authorisations
  • Safety and effectiveness
  • Monitoring and availability
  • Joint services

In addition, the Information and Development Services Unit and Communications Unit operate directly under the Director General.

The organisational restructuring was planned and prepared in cooperation with the personnel and supervisors, and the new organisational structure will be introduced on 1 March 2022. The reform will continue with the organising and developing the activities of the areas of responsibility.

Fimea’s strategy