Advanced therapy medicinal products (ATMP) represent a heterogeneous group of medicinal products, combined with the need for special regulation of their circulation. ATMP is a gene therapy medicinal products, a somatic cell therapy medicinal products, a tissue engineered products and combined ATMPs. The regulatory framework for ATMPs is established by Regulation (EC) No 1394/2007 on ATMPs which is designed to ensure the free movement of these medicines. The Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) was established in accordance with the Advanced Therapies Regulation as a multidisciplinary committee, whose primary responsibility is to assess the quality, safety and efficacy of ATMPs, and to follow scientific developments in the field. Since June 2009 the CAT issues scientific recommendations on ATMPs classification. CAT defines the strategy for the identification and analysis of risks associated with the clinical application of ATMP and risk factors determined by the quality of the product and the ratio of benefit-risk. The article presents methods of analysis of risk factors in the study of ATMP.

Neural tube defect relates to congenital defects caused by folic acid deficiency or violation of its exchange. Prophylactic administration of folic acid by pregnant women has greatly reduce the incidence of these malformations. However, despite preventive measures, reports of such serious adverse events continue to be recorded. The analysis showed that one of the possible causes of malformations may be the presence of the polymorphism of the gene encoding 5, 10-methylenetetrahydrofolate. The effect of this mutation on the metabolism of folic acid and possible recommendations to patients are discussed.

15-25% of cases of the medicatiom errors caused by the similarity in spelling or pronunciation of their names. The labelling may be a means of protection against such errors. The authors proposed a way of marking that is applied to each unit product information protective barcode labels containing identification and content information. The label is additionally equipped with a diffractive element copy protection, with a surface microrelief, creating the effect of optical diffraction, and the information that should be included in bar code originally entered into the Central computer control institutions of the supporting documents provided by the supplier for each delivered batch of goods, and then by computer conversion of this information on a predefined algorithm that transforms the data from supporting documents by a specific rule that specifies a particular responsible person of the region by entering the password in the set of symbols form a bar code and produce printing batches of labels in the statement of the provider number for a label on each unit of production with application to each barcode labels, and vending facility shall review products by visual inspection of the presence of the diffraction element and the read bar code labels are scanned per unit of output with simultaneous inverse transformation according to a predefined algorithm included in the bar code information and comparing the information from supporting documents submitted by provider for each delivered batch.

The authors prepared proposals for preventing undesired reactions at application immunobiological medicinal products in the Russian Federation. Given the significant number of osteitis when carrying out vaccination against tuberculosis in a nursing home as BCG and BCG-vaccine, it is proposed to consider with experts of the respective profiles of the question of the possible adjustments in the existing system of prevention of tuberculosis. To ensure timely diagnosis "BCG-ASTIC and destination specific treatment of the disease to carry out consultation with the coordinators of all children under the age of 5 years with a diagnosis of "octet" regardless of the localization of the inflammatory process. When exercising pharmacovigilance for side effects of vaccination against tuberculosis note that unlike bone tuberculosis caused by virulent bacteria, and striking in most cases, the spine, BCG osteitis virtually no this localization, and strike thigh 21, 2% of cases, tibia and fibula - 20%, sternum - 15, 6%, humerus and 11.6%, the bones of the foot is 9, 3%, fin - 8, 5%. It is considered necessary to conduct a complete replacement drugs heterologous sera, especially tetanus toxoid and rabies immunoglobulin from the serum of a horse, on preparations of human serum, as it is implemented in all developed countries. This event will lead to the exclusion of the possibility of allergic reactions of immediate type, including anaphylactic shock, when an emergency prophylaxis of these infections. Registration sterile abscesses after application of drugs DTP vaccine and the absence of such complications after the use of other adsorbed preparations (for example hepatitis In vaccines and vaccine encephalitis) do not exclude the possibility of communication first with the quality of the used sorbent and this allows us to recommend further study and evaluation of physicochemical parameters of the series of sorbent, used in the production of adsorbed vaccine containing the pertussis component.

Comparative evaluation of information about adverse reactions to medicinal products was carried out on the basis of the research data registered in specialized databases WHO, Russia, Switzerland, USA and the Republic of Kazakhstan. Comparative evaluation of the results of safety monitoring medicines showed that in the Russian Federation the average reporting about adverse reactions below the level recommended by WHO and countries with the most effective system of pharmacovigilance, such as the USA or Switzerland, but higher than in the Republic of Kazakhstan.