The Order of the Ministry of Health of Ukraine dated June 20, 2018 No. 1178 approved and entered into force on July 1, 2018, the Supplement No. 3 to the State Pharmacopoeia of Ukraine (II Edition) (SPhU 2.3) prepared by the State Enterprise “Ukrainian Scientific Pharmacopoeial Center for the Quality of Medicinal Products “( Pharmacopoeia Center) with the involvement of leading scientists of Ukraine in the field of pharmacy and veterinary medicine.
In SPhU 2.3 for the first time, the focus is on quality issues for medicines at European Pharmacopoeia level, which is one of the requirements for the export of livestock products to the European Union. A huge amount of work was carried out in close cooperation with the Pharmacopoeia Center with the State Research Institute of Biotechnology and strains of microorganisms, the State Scientific-Research Control Institute of Veterinary Preparations and Feed Additives and the National Center for Microorganism Streams.
Also, the traditional directions for SPhU are highlighted: general articles, general monographs, monographs on dosage forms, monographs on medicinal plants of raw materials and medicinal herbal preparations, monographs on pharmaceuticals (finished medicines).
It should be noted that in the SPhU 2.3, the process of harmonizing the terms of the SPhU with the actual translation and content of the terms of the European Pharmacopoeia continues. This is reflected in the Introduction, in a series of reviewed general articles, general monographs, monographs on dosage forms, monographs on medicinal plant raw materials, etc.
The development of monographs on medicinal plant raw materials remains one of the priority directions of development of the State Joint-Stock Company. To SPhU 2.3, 32 monographs on LRC and medicinal plant raw materials were introduced, of which 20 were new and 12 updated. They were developed by the Pharmacopoeia Center in cooperation with the National Pharmaceutical University. Much of the European monographs on the LRC, LRP is accompanied by significant national units that take into account national specifics. In addition, 4 monographs are national.
To SPhU 2.3, the national annex to Article 2.9.20 was first introduced. Mechanical inclusions: Visible particles, in which the criteria for controlling visible particles in the finished product are first established.
To SPhU 2.3 the national articles on substance and the ready-made dosage forms of cyticoline, which are manufactured according to different technologies, were introduced for the first time. Their development according to the requirements of the European Pharmacopoeia took more than 2 years and caused the need to find a balance between the pharmacological model of impurity regulation and the US Pharmacopeia approach, which takes into account not only their toxicity, but also the proper level of production technology.
In addition, in the SPhU 2.3, the European Pharmacopoeia monograph on oxygen was introduced for the first time, which allows us to consolidate the European quality of this important medical product.
A source http://www.diklz.gov.ua/control/main/uk/publish/article/1150124
