State Pharmacopoeia of Ukraine: present and future Maryna Dmitriieva Scientific Secretary of Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines Chinese Pharmacopoeia Scientific Symposium of September, 2015

1 Status of the State Pharmacopoeia of Ukraine

SPU 1 Outcome First pharmacopoeia among the former USSR countries Basis for all other regulation documents for medicines RS system was created Pharmacopoeial Ukrainian language established Handbook and tutorial for students and specialists an observer of the Ph. Eur. Commission 1998 Ukraine is a voting member of the Ph. Eur. Commission 2013 Historical Overview

3 The ratio of SPU 2.0 and Ph. Eur. items GCs and texts Vaccines Immune sera Radiopharmaceuticals Suture material Herbal Drugs Homeopathic API Finished products Compounding Dietary supplements SPU 2.0 Ph.Eur. 8.2 SPU 2.0 features Actualization ~800 GC and Monographs of SPU 1 National parts of many chapters are excluded National parts that remain are for advisory and informational purposes Development FP monographs further development National parts and national monographs for Herbal Drugs and preparations Texts on new areas of medicines (DS,CP)

4 Mechanism of SPU

5 Continuous transition to the direct using of the Ph. Eur. texts without translation Inclusion of the texts which are important for Ukraine but not presented in Ph. Eur. Dietary Supplements Compounded Preparations Metrological support of QC Medicinal cosmetics API Excipients Reagents The concept of SPU further development

6 The concept of SPU further development

7 The concept of SPU further development

8 The concept of SPU further development

9 The concept of SPU further development

10 The concept of SPU further development

11 The concept of SPU further development

12 Dietary Supplements Herbal ingredients Monographs and GCs for Herbal drugs and preparations Compounded Preparations Herbal infusions Herbal teas Honey preparations The concept of SPU further development

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