Step forward of Macedonian Agency for medicines and medical devices Establishment and strategic plan for development

Abstract

Abstract

Macedonian Agency for Medicines and Medical Devices (hereinafter: the Agency) on September 16 2014 has been established as an independent regulatory authority. Founder of the Agency is the Government of the Republic of Macedonia. Institutional building of the Agency is an important part of implementation of national medicines and medical devices policy aimed at ensuring access to medicines meeting recognized EU standards of quality, safety and efficacy as well as access to medical devices, meeting essential requirements set in EU legislation. It can be ensured by setting up efficient regulatory system, so the Agency should quickly develop its capacity in order to be able to ensure unimpeded transition from the Drug Bureau, to ensure its proper development and to play a key role in implementing the said aims. First strategic plan for the development of Macedonian Agency is for the period 2015-2017. This is a key period of action of this institution because it sets the groundwork for future work of the new competent authority for medicines and medical devices, which is built on the foundations of the Bureau of medicines. Agency Strategic Plan reflects not only the present moment, but also our duty to make the best possible way we fulfill our mission and develop the Agency in accordance with our vision. The new legal organizational structure allows us professional independence and the necessary flexibility. The strategic plan of the Agency allows to be based on an analysis of the current situation and the vision of who we want to become at the end of a given period.