Regulatory authorities should carry out an assessment of the PSUR, identifying possible new identified risks and their impact on the assessment of the benefit-risk ratio of the medicinal product. Based on the results of the assessment, the regulatory authority determines the need to perform further studies/tests on the safety or efficacy of the medicinal product, take regulatory actions regarding the registration status of the medicinal product, or amend the instructions for medical use of the medicinal product in order to ensure its use when the benefit exceeds the risk.
- presentation of a comprehensive and critical analysis of the benefit-risk relationship of the medicinal product, taking into account all new safety data and their cumulative impact on the safety and efficacy profile of the medicinal product.
The marketing authorization holder should continuously assess and analyze the impact of new data on the benefit-risk ratio, re-evaluate this indicator, and determine the need to optimize the benefit-risk ratio by introducing effective risk management measures and minimizing them when new information is revealed. on the safety of the medicinal product in the process of its post-registration use.
The assessment includes the following steps:
- critical analysis of all safety information received during the reporting period with the identification of possible identified new signals indicating new potential or identified risks or supplementing existing knowledge on previously identified risks;
- critical synthesis of all information received during the reporting period on the safety and efficacy of the medicinal product (both in the framework of clinical trials / trials, and in medical practice) with an assessment of the impact of these data on the benefit-risk ratio of the medicinal product;
- performing an integrated benefit-risk analysis based on all cumulative data available for the period from the date of first registration in any of the countries, the date of first registration for an interventional clinical trial in any of the countries;
- generalization of information on risk minimization measures that could be implemented or are planned;
- definition of a signal and risk assessment plan and/or proposals for additional pharmacovigilance activities.*
* – Based on GOST R 57690-2017