Pharmacovigilance — scientific and practical activity related to detection, assessment, understanding and prevention of adverse drug effects or any other drug-related problems. Medicines safety vigilance is one of the main trends in implementation of the national drug policy in all the countries worldwide.
The pharmacovigilance system in Ukraine has been operating since 1996. Since 2002, Ukraine has been the member of the International WHO program on the drug safety monitoring which shows the compliance of the pharmacovigilance system in Ukraine to worldwide standards.
The pharmacovigilance in Ukraine is regulated by the Order of the Ukrainian MoH dated 27.12.2006 № 898 “On approval of the pharmacovigilance procedure over adverse reactions of drug products approved for medical use” (registered in the Ukrainian Ministry of Justice dated 29.01.2007 № 73/13340). The document has been harmonized with the international pharmacovigilance approaches (WHO) and the European legislation (Directive of the European Parliament and EU Council dated 06.11.2001 d. № 2001/83 EU).
In accordance with Order of the Ukrainian MoH dated 27.12.2006 № 898, the Ukrainian Ministry of Health has delegated the responsibility on drug safety vigilance to State Enterprise “State Expert Center of MoH”. The state pharmacovigilance system is presented by the central chain — the Department of the post-marketing vigilance of SE “State Expert Center of MoH” and regional Department divisions which operate in all regions of Ukraine.
Since 30.10.2017, the obligatory provision for applicants in drug registration and re-registration is to provide Risk Management Plans and Drug Clinical Review Addendums. (DCRA, see more detail in section Drug Clinical Review Addendum (DCRA). The requirement has come into force after approval and enactment of the Procedure for expertise of drug registration materials which are submitted for state registration (re-registration), as well expertise of materials on introduction of changes to registration materials throughout the term of a marketing authorization approved by the Order of the Ukrainian MoH dated 26.08.2005 № 426 (as revised by the Order of the Ukrainian MoH dated 23.07.2015 № 460) registered in the Ukrainian Ministry of Justice dated 07.10.2015 № 1210/27655. Nowadays, applicants are given 2-year transition period to prepare the documents.
We provide the following services:
1. Preparation of periodic safety update reports (PSUR).
A periodic safety update report (PSUR) – a written report which contains periodic updated information on a drug safety. PSUR allows to make a periodic evaluation of safety data of authorized drugs, whether the data obtained during a reporting period comply with the available safety data related to the medical use of the drug in all the countries in which the drug has been registered. Therefore PSUR allows to summarize all new data on the drug safety obtained from various sources; to prepare the updated patient information; to summarize the experience of drug administration in various countries; to introduce changes to the drug administration strategy.
2. Preparation of the Risk Management Plans (RMP).
Risk management plan (RMP) – a detailed description of measures provided in the risk management system. RMP should define or characterize a drug safety profile, state how to characterize subsequently the drug safety profile, to document the measures for prevention or minimization of the drug-related risks including efficacy assessment of the measures, and document post-marketing obligations which have postulated the issue of the marketing authorization.
3. Creation of the master file of pharmacovigilance system.
Master file of pharmacovigilance system – a detailed description of a pharmacovigilance system which is used by a marketing authorization owner regarding one or more authorized drugs.
4. Monitoring of medical information sources and scientific periodicals.
Training of applicant personnel to pharmacovigilance skills. Initial, recurrent, routine training.