The State Service of Ukraine became one of the participants of the preliminary comparative analysis of the regulatory system of Ukraine – pre-benchmarking.
What is the event and what is the purpose?
The purpose of the event is to help the national regulatory authority to complete the self-assessment phase, as well as to plan and prepare for the upcoming formal benchmarking. The global assessment of Ukraine’s national regulatory system will start in 2021 and is scheduled to be completed in 2024. The duration of the WHO mission that will carry out the global assessment and the dates will be determined in October.
The self-assessment is the first step towards the implementation of the World Health Organization’s assessment procedure of the national regulatory system for medicines and vaccines in order to support it.
Specialists of the State Drug Control Service analyzed and provided detailed answers regarding competencies, functions, structure of pharmacovigilance.
Background: The WHO Global Benchmarking Tool is used as the primary means by which WHO assesses the performance of regulatory systems in the regulation of medicines.
As we wrote, WHO is making this assessment to support Member States in strengthening their regulatory systems. The Global Benchmarking Tool is the primary means by which WHO objectively assesses regulatory systems and incorporates the concept of “maturity levels” or ML, according to the Ministry of Health’s press center.
The maturity scale contains a maximum of 4 levels: from the first (presence of some elements of the drug market regulation system) to the fourth (the national pharmacovigilance system operates at an advanced level of performance and is constantly being improved).
The Ministry has completed the procedure of self-assessment of the national regulatory system, namely analyzed Ukrainian pharmacovigilance on 269 parameters, successfully verified the self-analysis with a group of WHO experts in a series of meetings and outlined a plan for the next steps.
Ukraine strives to obtain the third level of maturity assessment of the national pharmacovigilance system from WHO. We have successfully completed the procedure of pre-benchmarking – validation of self-assessment, received recommendations from WHO technical experts and are forming three groups of national experts who will go to the WHO delegations to the Philippines, Egypt and Malaysia as observers. They will use the gained experience to understand the process and qualitative preparation for direct assessment of the national regulatory system of Ukraine during benchmarking by WHO”, – said Deputy Minister for European Integration Maryna Slobodnichenko.
All countries that apply to WHO to benchmark their regulatory system follow a clear process: first a self-assessment of the national pharmacovigilance system is conducted, then this self-assessment is validated by WHO experts, and only then is the formal benchmarking process conducted.
The regulatory system is assessed in 9 areas: the overall structure of the country’s pharmaceutical regulatory system and its eight functions – drug registration and marketing authorization, pharmacovigilance, supervision and control of the drug market, regulatory inspections, laboratory research, supervision of clinical trials of drugs and the national regulator’s authorization procedure for the release of series of drugs – are examined.
