History of QKKB

 

The National Center for the Control of Drugs is a government institution responsible for the state control over drugs. It is founded in 1965, in analogy with similar institutions in other countries; the organization of the work in sectors is conceived in accordance with the orientations of OBSH (WHO-World Health Organisation). Initially, it began under the name of State Laboratory for the Control of Drugs.  During the first years the number of drugs passing the laboratory control was limited and they were mainly composed of the pharmacies’ preparations.

In 1968, the Laboratory being transferred from the premises of “Profarma” to independent premises, as well as the necessary framework being fulfilled, the control expanded. The pharmaceutical raw material that entered principally through Fu-Farma, the different pharmacies’ preparations of the closed and open circle all over the country, “Profarma” products and, later on, the products of the Antibiotics Plant, as well as a limited number of imported preparations, were the target of this control. In general, there existed the laboratory basis for the implementation of analysis methods in accordance with the requirements of different farmakope .

It can be said that from those years a wholesome tradition of laboratory work has been inherited. With the passing of time the analytical laboratory has been continually supplied with modern equipments that have validated an analytical control in accordance with the contemporary requirements and standards.

Until 1992 the greatest number of analyzed samples consisted of pharmaceutical raw material. It can be said that, with the passing of time, the pharmaceutical specialties have significantly prevailed.
 
In 1993, by means of a Decision made by the Council of Ministers, nr.60, on 11.02.1993, the Laboratory was named the National Center for the Control of Drugs (Q.K.K.B), retaining almost the same organization structure.

After the passing of the law “On Drugs”, on 20.04.1994, the Inspection Sector as well as the Drug Registration Sector were added to the National Center for the Control of Drugs (Q.K.K.B); besides, in 2004 the foundation of the Information and Foreign Relations Sector was approved.

Currently, the National Center for the Control of Drugs (Q.K.K.B) represents an institution specialized in the analysis, control, and registration of drugs and it carries out its activity being controlled by the Ministry of Health. At present 56 employees work at the National Center for the Control of Drugs (Q.K.K.B), in these sectors: Analysis Sector (physical-chemical and microbiological analyses), Inspection Sector, Drug Registration Sector, Information and Foreign Relations Sector, Economic (Finance) Sector, Juridical-Administrative Relations Sector.