THE ROLE OF DRUG MANUFACTURERS IN THE MODERN PHARMACOVIGILANCE SYSTEM

Introduction. Russia began setting up a pharmacovigilance system in 1969. Now the latter plays a crucial role in public health due to the high consumption of medicines. Work has been done continuously over the past 10 years to harmonize the requirements of international (in particular, European) and Russian legislations on pharmacovigilance and pharmaceutical safety, which leads to more responsibility of manufacturers/drug registration certificate holders. Objective: to reveal the role of drug manufactures in the modern pharmacovigilance system. Material and methods. The investigation objects were the information letters published on the website of the Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being, the internal documentation of manufacturers for monitoring the safety of medicines. The investigation used methods for comparative analysis, questioning, and interviewing. Results. The information portal of the Russian Federal Service for Supervision of Consumer Rights Protection and Human Well-Being published more than 500 information messages in the period from 2011 to the first quarter 2018. It was found that the manufacturing companies began to more actively submitting information on the safety of medicines in 2017. The companies usually provide new safety data to amend the instructions for use, as well as new information on the use of drugs during pregnancy and breastfeeding. Surveys and interviews with specialists responsible for the pharmacovigilance system among 8 large foreign manufacturers showed that only 4 of them had fully set up a pharmacovigilance system and done its master file. Conclusion. Harmonization of the requirements of international and Russian legislations and approval of the good pharmacovigilance practice (GVP) rules are a strong impetus to setting up a pharmacovigilance system of manufacturers/drug registration certificate holders for the continuous monitoring of adverse events and their submission, as prescribed by law.