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State Pharmacopoeia of Ukraine:
present and future
Maryna Dmitriieva Scientific Secretary of Ukrainian Scientific
Pharmacopoeial Centre for Quality of [email protected]
Chinese Pharmacopoeia Scientific Symposium 23-24 of September, 2015
2
SP
U
sta
tus • According to the Medicinal Product Law
the State Pharmacopoeia of Ukraine is a legal act. Its requirements are mandatory for all enterprises and institutions of Ukraine that produce, store, distribute and use medicines, irrespective of their ownership
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
1.1
2.0
1.01.1
1.2
1.3
1.4
• an observer of the Ph. Eur. Commission
1998• Ukraine is a voting
member of the Ph. Eur. Commission
2013
Historical Overview
4
EФ 8.2ГФУ 2
29512969
57143
1212
170
1212
3721674
628
60
10
1350
170273
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 featuresActualization
• ~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)
5
SPU elabora
-tion
Reference
Standards
System• ~700 items
• Chemical RS• impurities
(~150)• Herbal RS
• individual• summary
(~50)
PTS
• Effective SPU feedback
• 11 rounds• ~60
participants/round• 18 compendial
methods
Mechanism of SPU
6
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 supportof QC
Medicinal cosmetics
API
Excipients
Reagents
The concept of SPU further development
7
The concept of SPU further development
SPU 2.0 most completely covers the Ph. Eur. GCs.• GCs often contain National Parts• Entirely national GCs
Maintain an actualized translation with national additions in SPU in foreseeable future.
National GCs further development • Metrological Support of Quality Control
• National GC Statistics update• Standardized validation procedure for different
pharmacopoeial methodics• Metrological supplements to the GCs
General Chapters
8
The concept of SPU further development
Unlike the GCs the problem of an official translation for API and excipients is not actual:GMP requirements are mandatory in Ukraine Manufacturers often use Ph. Eur. Monographs in the original language for API and excipients quality controlThe vast majority of substances in Ukraine are imported. Current Ph. Eur. requirements are usually used.Exception – National monographs on APIs and excipients
APIs and excipients Monograph
s
9
The concept of SPU further development
List of FPP monographs for inclusion in the pharmacopoeia is discussed by the SPU Working Party on the basis of the List of essential medicines and the needs of the registration bodies and manufacturers
Development of national monographs in accordance to manufacturers orders
The development of Finished Products monographs based on the British Pharmacopeia and the United States Pharmacopeia under previously signed agreements
135 FPP Monographs
Monographs on
Finished Pharmaceuti
cal Products
10
The concept of SPU further development
Different approach to standardization• Dog rose in the EP is standardized by
ascorbic acid content• Dog rose preparations in Ukraine are
divided into 2 species that are standardized by organic acids or carotenoids content
170 monographs on Herbal drugs and Herbal drug Preparations in SPU 2.0
27 monographs have significant National parts19 monographs are entirely
National
Monographs on Herbal drugs and
Herbal drug
preparations
11
The concept of SPU further development
Development of pharmacopoeial quality standards for compounded preparations is one of the priority directions of SPU further elaboration
A national concept of CP quality is currently under developmentClose collaboration with National University of Pharmacy
Experience of the leading pharmacopoeias and national specific application is widely used
National Chapters
on Compound
ed Preparatio
ns
12
The concept of SPU further development
Development of pharmacopoeial quality standards for Dietary Supplements is an important direction for further elaboration of SPU
A national concept development is required. Close collaboration with the Institute of Hygiene and Medical Ecology and National University of Pharmacy
The leading Pharmacopoeias experience with the national specific application is widely used
National Chapters
on Dietary Suppleme
nts
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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
14
