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International support to the development of the Agency
In September 2005, the Minister of Health of the Republic of Serbia, a representative of the European reconstruction Agency and the director of the Serbian Agency for Medicinal Products and Medical Devices signed, upon the published tender, the consent on conducting of the Twinning Project.
The Project worth EUR 1,200,000 shall be realized between the Serbian Agency for Medicinal Products and Medical Devices and the French Agency for Medicinal Products (Agence francaise de sécurité sanitaire des produits de santé - AFSSAPS), namely in the period 2006 – 2008.
According to this Project, experts from all fields of work in the Agency shall be educated at the French Agency for Medicinal Products, as well as in other agencies in the countries within the European Union, thus making contacts and partnerships in further work with their colleagues from those agencies.
This Project resulted in reaching the standards of the most developed European agencies and thus the acknowledgement of the activities carried out by the Serbian Agency for Medicinal Products and Medical Devices.
The Project should also facilitate the development of infrastructure in the domain of clinical trials, advance monitoring of adverse reactions to medicinal products, facilitate preparation and entrance of Serbia into the international network of GMP inspectors, etc. The Serbian Agency for Medicinal Products and Medical Devices and its activities were highly marked by the most significant international organizations (WHO, EDQM...).
It was thereby implied that the Agency was an organization with clearly defined goals and strategy of further development and emphasized that the Agencyۥs expert team was young and motivated. The Management of the Agency was evaluated as highly dedicated to further progress, and it was recommended that the cooperation with the European Union and other international organizations should be continued, in order to reach as fast as possible the ultimate goal, i.e. international acknowledgement of Good Regulatory Practice – GRP within the Agency.
Representatives of the Agency participate on a regular basis in the work of European Directorate for the Quality of Medicines – EDQM. As valid member of the Official Medicines Control Laboratory (OMCL) Network, the Agency, that is the National Control Laboratory has established exceptional cooperation with other European laboratories, which contributes to the improvement quality of work and provision of services to the Agencyۥs clients. Membership in this Network imposes the obligation of implementing all requirements of strict international standards in the field of quality control of medicinal products and medical devices. Therefore the National Control Laboratory has successfully implemented all requirements from ISO/IEC 17025:2005, but all additional requirements of the OMCL Network, set forth in the from of OMCL guidelines.
High quality of work in the National Control Laboratory verifies by regular participation in the Proficiency Test Studies (PTS), which present the form of comparing the quality of the results reached in clinical trials, carried out in the European laboratories. The results of the National Control Laboratory have traditionally been on the very top, which represents the confirmation of good quality work. Harmonization of the National Control Laboratory management system with the requirements of ISO/IEC 17025:2005 shall be examined by the experts from EDQM in 2007. Positive mark of this harmonization shall enable the National Control Laboratory to be accredited as a laboratory for the quality control of medicinal products and medical devices, which shall be the final step in the acknowledgement thereof in the OMCL Network and Europe in general. The Serbian Agency for Medicinal Products and Medical Devices closely cooperates with Uppsala Monitoring Centre, UMC, of World Health Organization (WHO), which is reflected by the active participation of the National Pharmacovigilance Center in the system of spontaneous reporting, collecting and monitoring of adverse reactions to medicinal products.
The National Pharmacovigilance Center forwards estimated reports of adverse reactions of medicinal products which occurred on the territory of our country. On the other hand, in order to maintain good practice in pharmacovigilance, UMC communicates with national centers and informs them on generated signals (new suspected reactions to medicinal products), as well as on other safety information significant for rational use of medicinal products. The National Pharmacovigilance Center also has en insight into the UMC data base, which contains over 3 million reports on suspected adverse reactions from numerous countries all over the world, which represents significant source of information in the total assessment of medicinal product safety profile.
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