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Methodological recommendations for conducting preclinical and clinical trials

29.08.2019 Updated 11.03.2024 21593 views
Draft conclusion of the state HTA: trifluridine/tipiracil (LONSURF) dated 08.03.2024DOCX · 18 KB · 11.03.2024
Download Draft conclusion of the state HTA of trifluridine/tipiracil (LONSURF) dated 08.03.2024 (DOCX, 18 KB)
Information Report Regarding the Status of Clinical Trials in Ukraine in the Period from January 01, 2022 to December 31, 2022PDF · 1.4 MB · 13.03.2023
Download Information Report Regarding the Status of Clinical Trials in Ukraine in the Period from January 01, 2022 to December 31, 2022 (PDF, 1.4 MB)
Information brief on the state of clinical trials in Ukraine from 01.01.2022 to 31.12.2022PDF · 1.5 MB · 17.02.2023
Download Information briefing on the status of clinical trials in Ukraine from 01.01.2022 to 31.12.2022 (PDF, 1.5 MB)
Information note on the status of clinical trials in Ukraine for the period from 01.01.2022 to 31.08.2022DOCX · 175 KB · 21.09.2022
Download Information note on the state of clinical trials in Ukraine for the period from 01.01.2022 to 31.08.2022 (DOCX, 175 KB)
CT in Ukraine. Information brochure 2020 Ukrainian versionDOCX · 1 MB · 25.01.2021
Download Clinical Trials in Ukraine. Information brochure 2020 Ukrainian version (DOCX, 1 MB)
International ethical guidelines for health-related research involving humansPDF · 1.4 MB · 25.01.2021
Download International ethical guidelines for health-related research involving humans (PDF, 1.4 MB)
Preclinical safety pharmacology studies of medicinal products. Methodological recommendationsDOC · 86 KB · 25.01.2021
Download Preclinical safety pharmacology studies of medicinal products. Methodological recommendations (DOC, 86 KB)
Preclinical safety evaluation of medicinal products of biotechnological origin. Methodological recommendationsDOC · 156 KB · 25.01.2021
Download Preclinical study of the safety of biotechnology-derived medicinal products. Methodological recommendations (DOC, 156 KB)
General principles of preclinical and clinical studies of biosimilar medicinal products containing proteins obtained by biotechnology as the active substance (methodological recommendations)DOC · 377 KB · 25.01.2021
Download General principles of preclinical and clinical studies of biosimilar medicinal products containing proteins obtained by biotechnology as the active substance (methodological recommendations) (DOC, 377 KB)
Information brochure on conducting clinical trials of medicinal products in pediatricsDOC · 22 MB · 25.01.2021
Download Information brochure on conducting clinical trials of medicinal products in pediatrics (DOC, 22 MB)
General Principles of the Organization of the Activities of Ethics Committees at Healthcare Facilities Where Clinical Trials of Medicinal Products Are Conducted (recommendations for experts)PDF · 1.1 MB · 25.01.2021
Download General principles of organizing the activities of ethics committees at healthcare facilities where clinical trials of medicinal products are conducted (recommendations for experts) (PDF, 1.1 MB)

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Forum "PHARMEXPERT 2026: pharmaceutical market in the new regulatory reality"
Forum "PHARMEXPERT 2026: pharmaceutical market in the new regulatory reality"
Forum "Clinical and preclinical studies in wartime: organization and development prospects"
Forum "Clinical and preclinical studies in wartime: organization and development prospects"
Pharmaceutical forum "PHARMEXPERT 2025. eCTD and pricing in Ukraine – a strategic path to integration into the international regulatory space"
Pharmaceutical forum "PHARMEXPERT 2025. eCTD and pricing in Ukraine – a strategic path to integration into the international regulatory space"
PHARMEXPERT 2024. Standards. Innovations. European integration
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Наказ МОЗ України від 2 жовтня 2026 №1467
# Заявникам # Експертиза матеріалів доклінічних та клінічних випробувань # Накази МОЗ про проведення КВ / СП
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Наказ МОЗ України від 2 жовтня 2026 №1491
# Заявникам # Експертиза матеріалів доклінічних та клінічних випробувань # Накази МОЗ про проведення КВ / СП
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List of registration forms submitted for state re-registration in the period from 28.09.2026 to 02.10.2026
# For applicants # List of applications for state registration of medicinal products
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List of registration forms submitted for state registration in the period from 28.09.2026 to 02.10.2026
# For applicants # List of applications for state registration of medicinal products
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Registration certificates to order No. 1340
# For applicants # Information on signed registration certificates
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Latest Announcements

Competitive selection of members of the HTA Expert Committee: deadline for submitting documents – until 12 October 2026

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Updated! List of original (innovative) medicinal products registered in Ukraine as of 07.09.2026

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Attention to business entities engaged in retail trade of medicinal products on the market of Ukraine! We provide lists of over-the-counter medicinal products by their storage conditions

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The Center recommends including the dual combination of umeclidinium bromide and vilanterol in the National List of Essential Medicines

The Center recommends including the dual combination of umeclidinium bromide and vilanterol in the National List of Essential Medicines 

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Representatives of the Center exchanged experience in the field of HTA with Swedish colleagues

Representatives of the Center exchanged experience in the field of HTA with Swedish colleagues

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Ukraine has updated approaches to the rational use of antimicrobial medicinal products in healthcare facilities

Ukraine has updated approaches to the rational use of antimicrobial medicinal products in healthcare facilities

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