Regulatory Challenges in the CIS and Russia - TOPRA In CEE WebinarNovember 22, 2023
Features of Choosing the Type of PIL RUT in EAEU
By the end of 2025, all registration dossiers for medicines should be brought into compliance with the EAEU rules.
Readability User Testing (RUT) of Product Information Leaflet (PIL) is one of the main stages in this process and remains an actual issue for many pharmaceutical manufacturers. During user testing, various parameters are considered and one of them is the type of testing. The choice of testing type significantly impacts the time spent on both testing and the registration process as a whole, the amount of resources expended, and often the final result.
For example, as part of registration procedures for medicinal products, applicants often receive comments from the regulator and are faced with the need to amend the draft PIL. This entails a review of the provided user testing results for the PIL and the organization of new testing. One of the challenges in this process is choosing the optimal type of new testing and justifying that choice (whether full testing, bridging, or focus group). The criteria for making this choice are not always clear, and in each case, there is a risk that experts might not accept the rationale for the chosen type of testing.
Alexander Leoshko, Head of the Operational Department at Inpharmatis, shared one of the practical examples related to the choice and justification for conducting bridging testing in the context of the registration process. “In this case, we are dealing with a manufacturer who has several flavors of the same medicinal product, and each flavor has a separate PIL The simple but inefficient solution would be to conduct full user testing for each flavor. However, our experts proposed an alternative approach: full testing for one flavor and additional bridging testing for the remaining flavors.”
“Making a decision on the choice of testing is an important stage where various factors should be taken into account. It is necessary to find a balance between compliance with regulatory requirements and saving time and resources,” says Alexander Leoshko, Head of the Operational Department at Inpharmatis.
One of the key tasks in this project was the selection and justification of the “parent” PIL, because the success of the entire project depended on this choice. Inpharmatis experts reviewed all available PILs and selected the one that contained the most key information for safe use as the “parent” leaflet. The test results were reviewed and approved by the regulator.
“Taking into account numerous factors, we have found a solution that combines compliance with regulatory requirements and resource savings. This case illustrates the importance of an individual approach in various situations,” says Alexander Leoshko.
Inpharmatis Group is one of the leading consulting companies in the EAEU and CIS markets, with many years of experience in conducting PIL Readability User Testing for various medicines belonging to different therapeutic groups. Inpharmatis has conducted hundreds of successful user testings in Russia, Belarus, and Kazakhstan (including testings in the Kazakh language), ensuring compliance with all EAEU regulatory requirements.
For more information, please contact us at: email@example.com.
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