Strategic planning is based on the monitoring and anticipation of change in an organisation’s environment that may significantly impact its operations and development. Our era is marked by extremely rapid changes in all areas of our lives. Digitalisation, automation, the internet of things, artificial intelligence, genomics, immuno-oncology, personalised medicine, cell therapy, unmet healthcare needs, new diseases and the redefinition of existing ones, and many other new approaches do not only reflect advances in technology but indeed shape the new mindset and influence the functioning of human society. Demographic change coupled with political and economic upheavals in the European Union (EU) and the rest of the world contributes significantly to these developments. 

It is therefore increasingly important to continuously follow the trends so as to be prepared to provide a timely and adequate response. The Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (hereinafter: the Agency) works in an environment very much influenced by social change and responds to such change in an appropriate manner. The health reform in Slovenia, the strategic guidelines in veterinary medicine and changes in the EU’s regulatory network pose new challenges to the Agency. The understanding and support of the founder and other key stakeholders are pivotal in this respect, as their cooperation is a precondition for the establishment of conditions enabling adaptation to change. To accomplish its mission, the Agency aims to actively co-create policies and regulatory requirements in its domestic environment.


The Agency is a respected and internationally well-established authority that meets its commitment to protect health with its expertise and independence and by taking into account those stakeholders’ expectations which are compatible with the Agency’s objectives.


In the fields of medicines, medical devices, blood, tissues and cells, we provide for the health of both people and animals, and as proposers of policies and coordinators of experts, we co-create the social environment. With our professional procedures, regulatory activities and supervision, we at the same time enable and promote the accessibility of products and the activities of stakeholders who contribute to advances in science and the profession to the benefit of the whole of society.

Development strategy 2018-2021 document is available at following LINK

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