National center

15.11.2012

The National Center was established by the decree of the Government of the Republic of Kazakhstan (RK) №1081 from 02.10.2002 “Special issues of the Republic governmental enterprise “The medicines center Dari-Darmek” of the Ministry of Health of the Republic of Kazakhstan

The National Center is considered as one of the structural parts of the integrated medicines, medical devices and equipment circulation system, responsible for provision of their safety, effectiveness and quality.

The National Center carries out exclusive function of dossier evaluation during the state registration of medicines, medical devices and equipment.

 

The main activities are

  • Conducting the evaluation of medicines, medical devices and equipment upon state registration
  • Certification of medicines
  • Development of the State Pharmacopeia of RK
  • Conducting the preclinical trials and bioequivalence studies of medicines
  • Participation in the pharmacovigilance and monitoring of adverse drug  reactions
  • Participation in the development of legislation
  • Conducting the expertise of advertisement/promotional materials on medicines
  • Support and maintenance of the Medicine’s State register database
  • Publishing the informational-analytical journal “Kazakhstan Pharmacy”
  • Maintenance of the departmental dossier archives
  • There are 11 territorial branches/units
  • There are 11 divisions within National center, including Testing Center (laboratory), Pharmacological center and Pharmacopoeia center