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Guidelines and methodological recommendations on conducting preclinical studies and clinical trials

29.10.2019 Updated 26.05.2026 61799 views
Methodological recommendations “GOOD RADIOPHARMACEUTICAL PRACTICE” (GRPP) FOR SMALL-SCALE PRODUCTION OF RADIOPHARMACEUTICALS”DOCX · 124 KB · 26.05.2026
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GUIDELINE ST-N MOHU 42-7.19:2026 “MEDICINAL PRODUCTS. Clinical trials of medicinal products for the treatment of epileptic disorders”PDF · 688 KB · 17.03.2026
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Methodological recommendations “Methodology of toxicological studies for assessing the safe use of novel substances in food products proposed for placing on the market as dietary supplements”DOCX · 111 KB · 28.10.2025
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Guideline ST-N MOZU 42–7.17:2025 “Medicinal products. Clinical trials of medicinal products for the treatment or prevention of diabetes mellitus”PDF · 685 KB · 25.09.2025
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Guideline ST-N MOZU 42–7.16:2025 "Medicinal Products. General Considerations for Clinical Trials ICH E8 (R1)"PDF · 541 KB · 30.04.2025
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Guideline ST-N MOZU 42–7.15:2024 Medicinal Products. Clinical Trials of Medicinal Products for the Treatment of Arterial HypertensionDOCX · 187 KB · 19.12.2024
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Guideline ST-N MOHU 42–6.6:2024 “Medicinal Products. Preclinical Biodistribution Studies of Gene Therapy Medicinal Products”PDF · 500 KB · 12.11.2024
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Guideline CT-N MoHU 42–7.14:2024 “Medicinal Products. Clinical Evaluation of Vaccines”DOCX · 153 KB · 19.08.2024
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Guideline ST-N MOHU 42–6.5:2024 “Medicinal Products. Inspection and Verification of Compliance with Good Laboratory Practice (GLP)”PDF · 447 KB · 15.07.2024
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Specifics of conducting clinical studies of medicinal products for the treatment of urinary incontinenceDOCX · 89 KB · 15.05.2024
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Medicinal products. Preclinical carcinogenicity studies of medicinal productsDOCX · 694 KB · 15.05.2024
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Medicinal products. Quality, preclinical and clinical aspects of medicinal products containing genetically modified cellsPDF · 1 MB · 28.02.2024
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Guideline Medicinal products. Detection of reproductive toxicity of medicinal products for medical useDOCX · 718 KB · 16.01.2024
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Specifics of conducting clinical studies of medicinal products for the treatment of Parkinson's diseasePDF · 988 KB · 14.03.2023
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Guideline ST-N MoHU 42-7.11:2022 "Medicinal products. General principles of preclinical and clinical studies of similar biological medicinal products containing biotechnology-derived proteins as the active substance"PDF · 1 MB · 23.01.2023
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Guideline "Medicinal Products. Preclinical Evaluation of Vaccines (ST-N MOZU 42- 6.2:2021)", approved by MoH order of 19.08.2021 No. 1765PDF · 708 KB · 01.12.2022
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Guideline “Medicinal Products. Preclinical Safety Studies in Support of the Development of Medicinal Products for Pediatric Use (ST-N MOHU 42-7.9:2021)”, approved by MoH of Ukraine order of 14.04.2021 No. 728PDF · 1.6 MB · 01.12.2022
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Guideline “Medicinal Products. Strategies to Identify and Mitigate Risks in First-in-Human and Early Clinical Trials of Medicinal Products”, approved by MoH of Ukraine order of 21.01.2022 No. 143PDF · 643 KB · 01.12.2022
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International ethical guidelines for health-related research involving humansPDF · 1.4 MB · 25.01.2021
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Preclinical safety pharmacology studies of medicinal products. Methodological recommendationsDOC · 86 KB · 25.01.2021
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Preclinical safety evaluation of medicinal products of biotechnological origin. Methodological recommendationsDOC · 156 KB · 25.01.2021
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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
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GUIDELINE MEDICINAL PRODUCTS NONCLINICAL SAFETY STUDIES TO SUPPORT CLINICAL TRIALS IN HUMANS AND MARKETING AUTHORIZATION OF MEDICINAL PRODUCTS (ICHM3(R2))PDF · 619 KB · 25.01.2021
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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
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Information brochure on conducting clinical trials of medicinal products in pediatricsDOC · 22 MB · 25.01.2021
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