The State Pharmacopoeia of Ukraine (SPhU) Supplement 4 is coming into force

Supplement 4 to the second edition of the State Pharmacopoeia of Ukraine (SPhU) is coming into force on 1 July 2020 by the order of the Ministry of Health of Ukraine dated 22.05.2020 № 1239 (SPhU 2.4).

A large part of information has been developed by the State Enterprise “The Ukrainian Scientific Pharmacopoeial Centre for Quality of Medicines” (hereinafter – Pharmacopoeial Centre) with involvement of leading professionals of Ukraine.

SPhU 2.4 develops priorities that were commenced in the previous supplements of the SPhU 2.4.

1. Sets standards of quality for biological medicinal products, including ones for veterinary.

 18 new monographs on vaccines for veterinary medicine (one of them is national “Live swine erysipelas vaccine”) has been included into SPhU 2.4. It’s necessary to mention the national monograph “Plasma for Laboratory Diagnostics in vitro^N“ and the article “Quantitative analysis of cardiac glycosides in vivo” (2.7. N.1) developed as an order of the national manufacturers.

The SPhU 2.4 jointly with 8 updated articles on quality control and 3 monographs (2 general, 1 individual) ensures improvement of the standardization of biological medicinal products.

2.Sets the standards of quality for raw medicinal plant materials and herbal medicines.

107 monographs have been introduced including 61 new and 46 updated. 15 of the above mentioned monographs are national. The new national general article “Storage of raw medicinal plant materials” (2.8.N.1) and updated general articles “Names of monographs on raw medicinal plant materials used in Chinese traditional medicine” (5.22) and “Names of monographs on raw medicinal plant materials and herbal medicines in Pharmacopoeia” (5.22.N) have been introduced.

3. Sets the database of national monographs on pharmaceuticals.

11 new monographs developed on a basis of agreements between Great Britain and USA have been introduced.

4. Development and actualization of national articles.

The general article “Validation of analytical methods and trials” (5.3.N.2) has been updated and contains the standard procedure of validation of nearly all the pharmacopoeial methods of analysis with examples of their use and real methods of quality control. The addition to the general article “Statistical analysis of the results of chemical experiment” (5.3.N.1) is a statistical basis of the article and places emphasis on technological studies.

5. Development of recommendations for the dietary supplements quality.

The updated general monography “Dietary supplements“ reflects new concept on this issue.

The development of the SPhU is a joint work of scientists, leading manufacutrers of medicinal products and Pharmaceutical Society.