REMEDIUM

Full transition to the single pharmaceutical market of the Eurasian Economic Union (EAEU) should be completed in 2025. Currently, the development of missing regulatory and methodological materials for regulating the circulation of medicines in the region, including the Current Good Manufacturing Practice (GMP) Regulations, continues. These Rules were conceived as an adapted translation of the relevant EU Guidelines, but there are certain differences from the Western European prototype. The article discusses significant differences affecting four aspects of GMP: the procedure for release of pharmaceutical substances, the mechanism of batch certification, the role of GMP in quality control of imported medicines and quality assurance in the production process of drugs for clinical trials. According to the Eurasian GMP Rules, Qualified Person is responsible for batch release of active pharmaceutical ingredients, while in the EU countries and in many other states this procedure is responsibility of the Quality Service. The decision of the qualified person on the batch release of medicines is documented with Certificate of Eurasian GMP compliance. However, in EU countries, the decision to release a batch is documented in the form of a record in a register or other database. According to the EU rules, the release of imported batches of finished pharmaceutical products into circulation is carried out in the recipient country, after drug products are moved across the EU's external customs borders. In the EAEU countries, the batches of imported drugs are controlled, certified and released in the country of production. The EAEU GMP Rules for the production of drugs for clinical trials, including the main text of the Rules and Appendix No. 13, contain a number of errors in translation and interpretation of the original EU standard. For example, instead of Clinical Trials Authorization of the drug, there is a link to the Clinical Trial Protocol. The original term «product specification file» is translated as «investigational drug dossier». The authors see the most relevant direction in the course of revising the previously adopted regulatory and methodological documents of the common Eurasian drug market in determining the role of a qualified person in the batch release of active pharmaceutical ingredients and setting the procedure for certification of batches of imported finished medicinal products. Also noteworthy is the task of updating the GMP requirements for the production of drugs studied in clinical trials.

Introduction. Herbal products represented at the market in the form of herbal medicinal products (HMP) and herbal dietary supplements (HDS) largely differ in the level marketing authorization requirements. In this regard, it is actual to study the issue of how legislative requirements affect the choice of alternatives in terms of registration of products to be launched. The purpose of the study was to conduct a comparative analysis of the registration requirements for HMP and HDS in accordance with the law of the Eurasian Economic Union (EAEU) and to assess the activity in the field of herbal products launches. Materials and Methods. The study was based on the marketing authorization legislation for HMP and HDS, as well as official information on registered products. Results. Transition to the EAEU legislation has led to a significant complication of the requirements for the HMP marketing authorization, while this has not happened for HDS. As well as in the period of validity of the national requirements on the Russian pharmaceutical market, the number of registered HDS is an order of magnitude higher than the HMP. In 2021-2022 136 registration certificates for HMP and about 2 thousand certificates for HDS were issued. The registration of 69 HMPs was canceled due to the need to bring the registration dossiers in line with the new requirements. Conclusion. The regulatory model created in accordance with the EAEU law, with a general increase in the quality and safety requirements for HMP and HDS, at the same time does not create the necessary incentives for registering herbal products as HMP. This problem solution is seeing, among other things, in the expansion of opportunities for using simplified procedures for registering PRPs.

The paper presents the results of a study of the self-assessment of the formation of digital competencies in medical professionals. The main conditions (installations of specialists) of professional digital competencies are defined: «orientation of the medical worker to the digital literacy of the patient», «use of information technologies and digital health products», «interaction with the patient using digital means», «the ability to assess the prospects for the use of certain digital technologies and products», «the ability to combine digital means and traditional methods of medical care», «the ability to objectively assess their own competence in the field of digital healthcare», «mastering digital competencies in the process of NMO», «independent mastering of digital competencies necessary for professional activity». According to the results of the study, it was determined that medical workers highly appreciate their own competence in matters of interaction with the patient using digital means and a combination of digital means and traditional methods of providing medical care. The medical specialists we interviewed the lowest rate their abilities in the independent development of digital competencies and in the process of mastering the NMO programs.

The article examines the state of the pharmaceutical industry in 1940—1942. in the USSR. The difficulties and shortcomings of the work of enterprises producing medicines, the measures taken by Narkomzdrav to establish and put production capacities into operation as quickly as possible are shown. Data are given on specific measures that made it possible to cover the shortage of personnel, minimize losses associated with the loss of many factories and the evacuation of enterprises to the eastern regions of the country, and optimize the production process. The role of the countries of the anti-Hitler coalition in providing medicines to the Soviet Union in the most difficult first years of the Great Patriotic War is indicated. The achievements of domestic scientists, in the most difficult conditions, developing new drugs are given.

This article presents an analysis of the routing of patients in the diagnosis of malignant neoplasms of colorectal localization based on the data of primary medical documentation at the place of diagnosis and retrospectively in outpatient facilities during preventive examinations and medical examinations.

Diseases of the bone system, in particular, osteoporosis is a global pandemic affecting children, men and women, regardless of age. The basis of its treatment is the use of antiresorptive and anabolic drugs, as well as calcium and colecalciferol preparations. Currently, a large number of trade names of drugs for the treatment of osteoporosis are represented on the domestic pharmaceutical market, which determines the need for a structural analysis of the assortment. This article examines the range of drugs for the treatment of osteoporosis registered in the Russian Federation as of February 2023, according to the State Register of Medicines. The article indicates the distribution of drugs by dosage forms and pharmacotherapeutic groups, an assessment of the assortment renewal index was carried out and the value of the Vyshkovsky index was determined. A significant part of the drugs do not have domestic analogues and are represented only by foreign manufacturers, which dictates the need for early import substitution and the development of new drugs.

This article provides an overview of structure of monographs of The State Pharmacopoeia of the Russian Federation (XIV edition) according to origin of drug products and drug substances. Present article also provides data on comparative analysis of enacted monographs with The List of vital and primary drug products considering the dosage forms.

The article examines the implementation of the provisions and principles of the Alma-Ata Declaration of 1978 and the Astana Declaration of 2018 from the standpoint of a critical analysis of the success of the world community in implementing the concept of primary health care and achieving the Sustainable Development Goals. It is concluded that the Astana Declaration clarifies and concretizes certain provisions of the Alma-Ata Declaration on the political vision of primary health care (realization of the right to health to ensure health for all) and its applied essence. The political vision of primary health care is still relevant and even necessary to achieve the new principles of the World Health Organization and the Sustainable Development Goals.