The control of immunobiological preparations in Hungary and its importance for national vaccination programmes.

In Hungary the control of immunobiological preparations has been regulated by legal orders since 1938. In the meantime the pertinent rules have been modifed several times, to keep them abreast with current development. The authority of state control has been vested into the Vaccine Control Department of the National Institute of Public Health (OKI), which in this capacity has maintained an intensive collaboration with the producer of immunobiological preparations, the HUMAN Institute of Serobacteriological Production and Research (HUMAN). As a result, several important vaccine preparations (pox, DPT, DT, tetanus, typhoid and BCG vaccines) employed in compulsory immunization programmes have been improved considerably in respect of safety and efficiency, on the basis of laboratory tests, controlled field trials and epidemiological observations, described in detail in this review.