World Health Organization (WHO) initiated the specific project on prequalification of laboratories all over the world per UN request since 2005. The prequalification procedure is performed to ensure that laboratory complies with international quality standards. This is a voluntary procedure conducted for laboratories that are willing to test pharmaceutical products per UN agencies’ requests. The laboratory is granted with “prequalified” status if quality control procedures are found satisfactory by WHO and it is compliant with Good Practices for Pharmaceutical Quality Control Laboratories (GPCL) standard and Good Manufacturing Practice standard. WHO assessed five laboratories of «Scientific Centre for Expert Evaluation of Medicinal Products» («SCEEMP») in May 2016 and gave them a prequalified status. This status has already been granted to two «SCEEMP» laboratories before, so, seven «SCEEMP» laboratories are proven to be compliant with international standards now: Laboratory for Control and Coordination, Biotechnological Products laboratory, Nano-medicines laboratory, Cell and Gene Therapy Products laboratory; Vitamins laboratory, Hormones and Synthetic Analogues laboratory and Microbiology Laboratory. «SCEEMP» evaluates of new and generic drug registration dossiers and gives green light to Ministry of Health for drugs to be approved in Russia. Since 2002, organization ensures that medication is manufactured and marketed in accordance with quality, efficacy, and safety international standards. Since then, experts introduced not only ICH (International Conference on
Harmonization) standards but also US FDA and EMA regulatory experience into Russian regulatory practice. Moreover, «SCEEMP» has a variety of educational programs for industry. WHO recognition guarantees that organization strictly follows harmonization and standardization rules and had already reached international status. Today, prequalified status is granted by WHO only to 41 organizations all over the world.