One of the most important principles and mechanisms of the pharmacological control system is that only medicines registered and authorized by the state for medical use based on the totality of their pharmacological, toxicological and other quality characteristics may be manufactured and imported, sold and used in Ukraine. These requirements are ensured by a number of scientific-expert and regulatory structures of the Ministry of Health of Ukraine that perform control and permitting functions. Among them is the State Expert Center of the Ministry of Health of Ukraine, which, precisely thanks to its multidisciplinary and multifunctional system of organization, performs the responsible state and social tasks assigned to it. The main function of the State Expert Center of the Ministry of Health of Ukraine is scientific and organizational support for substantiating the authorization for medical use of exclusively quality, effective and safe medicinal products. In this area, the Center conducts expert evaluation of medicinal product materials for the purpose of their subsequent registration in Ukraine.
If we consider the history of the development of the State Expert Center of the Ministry of Health of Ukraine in relation to the relevant organizational, scientific-methodological and legal requirements and the content of the entire complex multi-stage activity of healthcare authorities, medical and scientific institutions involved in addressing the issues of medical use of medicinal products, one cannot leave out of consideration the most important stages of the Center's formation.
The creation and approval of a large-scale regulatory system of a pharmacological direction and oversight in Ukraine began back during the existence of the Soviet Union, when the Pharmacological Commission of the Ministry of Health of Ukraine was established. By order of the Ministry of Health of the USSR of 02.03.90 No. 97 "On improving the system of development of medicinal products in the Ukrainian SSR", a Pharmacological Commission was established under the Main Directorate of Science and International Relations of the Ministry of Health of the Ukrainian SSR, and its regulations were also approved. By this order, the Pharmacological Commission of the Ministry of Health of the Ukrainian SSR was delegated the right to independently decide matters related to permission for the first phase of clinical trials of medicinal (therapeutic, prophylactic and diagnostic) products developed in the Ukrainian SSR. In addition, this order provided for the creation of the Republican Center for Experimental Study of New Pharmacological Products being developed in research institutions of the Ukrainian SSR, which operated under the supervision and in accordance with the requirements of the Pharmacological Committee of the Ministry of Health of the USSR. Laboratories for the expert evaluation of materials from preclinical study of new medicinal products and of the regulatory and technical documentation for them were also established. The Pharmacological Commission was created and worked on the basis of the Kyiv Research Institute of Pharmacology and Toxicology of the Ministry of Health of Ukraine. The chairman of the commission was appointed as the then director of the Kyiv Research Institute of Pharmacology and Toxicology of the Ministry of Health of Ukraine, Doctor of Medical Sciences, Professor, Corresponding Member of the Academy of Medical Sciences of Ukraine Ivan Serhiiovych Chekman.
It is important to note that, despite its short period of activity (1989–1992 pp.) and the narrow scope of its powers under union legislation, the Commission was able to draw the attention of the republic's leadership to the real scientific and industrial potential of Ukraine.
After our young State gained independence, its leadership realized that one of the guarantors of Ukraine's sovereignty and a factor in its European orientation was an independent policy in the field of providing the population with medicinal products and the creation of its own system of medicines control. Thus, the first of the republics of the former USSR obtained the right to recommend medicinal products for medical use and to authorize and conduct clinical trials. Therefore, as early as 22 November 1991 (less than 2 months after the proclamation of independence), the Presidium of the Verkhovna Rada of Ukraine adopted Resolution No. 1853-XII, by which the Cabinet of Ministers of Ukraine was instructed: ...to resolve in the near future the issue of establishing the Pharmacological Committee of Ukraine...
In pursuance of this resolution, the Ministry of Health of Ukraine issued order No. 29 of 14.02.1992 "On the Establishment of the State Pharmacological Committee under the Ministry of Health of Ukraine."
Understanding that the establishment of the State Pharmacological Committee of the Ministry of Health of Ukraine requires time – to work out the range of tasks and the regulations necessary for its operation, to create the relevant regulatory framework and an effective structure – a well-founded decision was taken for the transition period to establish a temporary Pharmacological Committee under the Ministry of Health of Ukraine (which operated from 14.02.1992 to 04.08.1993) on the basis of the existing Pharmacological Commission of the Ministry of Health of Ukraine. The issue of financing its activities was also resolved. The Head of the temporary Pharmacological Committee under the Ministry of Health of Ukraine was appointed as the Head of the Department of the Kyiv Research Institute of Pharmacology and Toxicology of the Ministry of Health of Ukraine (now the Institute of Pharmacology and Toxicology of the Academy of Medical Sciences of Ukraine), Doctor of Medical Sciences, Professor Volodymyr Kondratiuk.
The Temporary Pharmacological Committee under the Ministry of Health of Ukraine carried out extensive organizational and scientific-methodological work. A structure was formed that ensured the fulfillment of the tasks assigned to it, primarily regarding saturating the market with the necessary medicinal products. Work regulations were also developed, and the procedure for conducting the expert evaluation of medicines was elaborated. In particular, the first "Regulation on the Registration of Medicinal Products of Domestic and Foreign Manufacture" was developed. The Regulation was discussed and approved at the first meeting of the committee, which took place on 26.03.1992 , and subsequently approved by 17.04.1992 of the Ministry of Health of Ukraine. By this Regulation, the Ministry of Health of Ukraine delegated to the committee the functions of the registration authority.
The first "Regulation on the Pharmacological Committee of the Ministry of Health of Ukraine" stated that decisions were adopted after their approval by the Presidium of the Committee. Meetings of the Presidium of the Pharmacological Committee of the Ministry of Health of Ukraine were held once a month. At these meetings, issues concerning the registration and re-registration of medicinal products of domestic and foreign manufacture were discussed and resolved; materials of preclinical and clinical study of medicinal products were considered; scientific and organizational issues were considered: methodological issues of clinical pharmacology, problems of adverse effects of medicines, instructions, specifications of medicines were reviewed, as well as issues of the work of structures, departments and subdivisions of the committee, regulations and normative documentation, etc.
With the renaming of the Temporary Pharmacological Committee under the Ministry of Health of Ukraine into the Pharmacological Committee of the Ministry of Health of Ukraine (in accordance with the Resolution of the Cabinet of Ministers of Ukraine of 20.09.93 No. 663 "On the work of the Ministry of Health of Ukraine regarding the provision of the population with medicinal products" 20.10.93), the Ministry of Health of Ukraine approved by its order No. 216 the structure and regulation on the Pharmacological Committee of the Ministry of Health of Ukraine. Thus, the period of formation of the system of state registration of medicinal products in Ukraine was completed, which guaranteed the entry onto the pharmaceutical market of effective, safe and quality medicines.
17 November 1992 saw the tragic passing of the first chairman of the Pharmacological Committee of the Ministry of Health of Ukraine, Volodymyr Yosypovych Kondratiuk. In our memory, Volodymyr Yosypovych remains an example of dedication to the cause, a person who directed all his vast experience as a talented scientist and organiser towards achieving one goal – establishing in Ukraine the foundations for the functioning of a modern system of medicinal product control.
In December 1992, the Pharmacological Committee was headed by the head of the Department of Oncopharmacology of the Institute of Pharmacology and Toxicology of the Academy of Medical Sciences of Ukraine, Doctor of Medical Sciences, Professor Nadiia Ivanivna Sharykina.
It should be noted that for a long time in Ukraine there was no clearly defined legal framework for regulating relations in the sphere of circulation of medicinal products. The time demanded the adoption of the Law of Ukraine "On Medicinal Products", which could become a kind of foundation for creating a regulatory and legal basis for authorising the use of medicinal products in Ukraine.
After lengthy work during 1994–1995, on 1 March 1995 the Verkhovna Rada of Ukraine adopted in the first reading the Law of Ukraine "On Medicinal Products", and on 4 April 1996 it was approved.
With the gaining of experience in the field of expert evaluation and registration of medicinal products and in implementation of the Resolution of the Verkhovna Rada of Ukraine on putting into effect the Law of Ukraine "On Medicinal Products" and the instruction of the Cabinet of Ministers of Ukraine, a whole series of the most important regulatory documents was approved by the relevant orders of the Ministry of Health of Ukraine, such as the "Regulation on the Registration of Foreign Medicinal Products in Ukraine", the "Regulation on the Registration of Domestic Medicinal Products in Ukraine" and other documents prepared by the Pharmacological Committee of the Ministry of Health of Ukraine during 1996–1997 pp. Many of them were introduced in Ukraine for the first time in its entire history. Work also began on creating the foundations for the control and evaluation of the results of preclinical and clinical studies of medicines. Work was carried out on the analysis of the pharmaceutical market of Ukraine, and the prospects for the development and introduction of domestic medicinal products were assessed. It also cannot be left without attention that, with the aim of improving the prompt resolution of scientific-organizational and certain current issues, the Presidium of the Pharmacological Committee and its Bureau were established within the Pharmacological Committee of the Ministry of Health of Ukraine.
In January 1996, the first issue of the information and analytical journal "Pharmacological Herald" was published. The journal has existed for 12 years. During this time, the editors and the composition of the editorial board changed, the name of the journal changed (since 2000 the journal has been published under the new name "Herald of Pharmacology and Pharmacy"), as did its design, but at all times the journal, as a printed organ of the Pharmacological Committee, performed its functions of informing a wide range of specialists about various aspects of its activities, the state of medicinal product registration, current views on the mechanisms of action of medicinal products and the specifics of their medical use, etc.
In 1995–1996, the conditions were maturing for initiating a new stage in the activity of the medicinal product quality control system in Ukraine, at which the main emphasis was to be shifted to supporting domestic manufacturers. To this end, the Government adopted Resolution No. 1069 of 5 September 1996 "On the Establishment of the Bureau of Medicinal Product Registration of the Ministry of Health of Ukraine" – a body delegated the authority to carry out "...registration of medicinal products on the basis of the recommendations of the Pharmacological Committee on the expediency and possibility of use of the medicinal products submitted for registration".
The Bureau received a number of functions that until November 1996 were the prerogative of the Pharmacological Committee of the Ministry of Health of Ukraine. Thus, the Bureau was granted the right to review materials submitted by the Pharmacological and Pharmacopoeial Committees regarding the specific activity of medicinal products, the possibility of their medical use, and analytical regulatory documentation; to carry out the registration of medicinal products of foreign and domestic manufacture; to establish, in accordance with the established procedure, temporary working groups with the participation of scientists and representatives of the relevant ministries, other central executive bodies and public organizations for the purpose of preparing materials for consideration at Bureau meetings, and so on. Accordingly, the status of the Pharmacological Committee changed, as it lost the functions of a registration body (until that time it was it that made decisions on the registration/re-registration of medicinal products, and the Chairman of the Committee signed the registration certificates). By order of the Ministry of Health of Ukraine dated 20.01.1997 No. 16, the Pharmacological Committee of the Ministry of Health of Ukraine was transformed into a scientific and expert state institution subordinate to the Ministry of Health of Ukraine.
Since January 1 1997, the committee has been headed by the Deputy Director for Research, Head of the Department of Pharmacology of Natural Compounds of the Institute of Pharmacology and Toxicology of the Academy of Medical Sciences of Ukraine, Doctor of Medical Sciences, Professor Volodymyr Semenovych Danylenko. During his leadership, in April 1998, the Resolution of the Cabinet of Ministers of Ukraine No. 569 "On Approval of the Procedure for State Registration (Re-registration) of a Medicinal Product and the Amounts of the Fee for State Registration (Re-registration) of a Medicinal Product" came into force.
In order to deepen approaches to assessing the quality, safety and efficacy of medicinal products, the National Agency for Control of the Quality and Safety of Food Products, Medicinal Products and Medical Devices was established. In accordance with Decree of the President of Ukraine L.D. Kuchma of February 1, 1999, No. 109/99 "On Improving State Control over the Quality and Safety of Food Products, Medicinal Products and Medical Devices", the National Agency was established on the basis of the Coordinating Expert Committee on the Quality and Safety of Food Products, the Committee on Hygienic Regulation, the Committee on Immunobiological Preparations, the Bureau of Medicinal Product Registration, the State Inspection for Drug Quality Control, the Committee on New Medical Equipment and the Pharmacopoeial Committee, which are being liquidated.
In 26.03.1999 the reorganization of the Pharmacological Committee of the Ministry of Health of Ukraine into a state enterprise – the State Scientific Expert Center for Medicinal Products (SSECMP) of the Ministry of Health of Ukraine – was carried out by order No. 69 of the Ministry of Health of Ukraine. It was headed by an employee of the Institute of Pharmacology and Toxicology of the Academy of Medical Sciences of Ukraine, Doctor of Medical Sciences, Professor Petro Ivanovych Sereda.
In February 2000, by order of the Ministry of Health of Ukraine No. 23 dated 15.02.2000, "On the reorganization of the State Scientific Expert Center for Medicinal Products", the state enterprise State Scientific Expert Center for Medicinal Products was reorganized into the State Pharmacological Center of the Ministry of Health of Ukraine. Academician of the Academy of Medical Sciences of Ukraine, Professor Oleksandr Viktorovych Stefanov – Director of the Institute of Pharmacology and Toxicology of the Academy of Medical Sciences of Ukraine – was appointed its director.
The State Pharmacological Center of the Ministry of Health of Ukraine retained succession both as the Pharmacological Commission (1989), the Temporary Pharmacological Committee of the Ministry of Health of Ukraine (1992), the Pharmacological Committee of the Ministry of Health of Ukraine (1993), and the State Scientific Expert Center for Medicinal Products of the Ministry of Health of Ukraine (1999).
The main goal of the Center's activity was defined as carrying out scientific, expert, advisory, production and other activities to protect the pharmaceutical market of Ukraine from dangerous and substandard products.
The Charter of the Center (approved by the Minister of Health of Ukraine V.F. Moskalenko in 2000) defined the main areas of its activity, namely: expert evaluation of medicinal products for the purpose of recommending them for state registration (re-registration); expert evaluation of materials from preclinical studies of medicinal products for the purpose of recommending them for clinical trials; organization and control of clinical trials; ensuring, within its competence, compliance with the principles of biological and medical ethics in the process of scientific research; approval of instructions for the medical use of medicinal products; matters of registration of substances; control of adverse effects of medicinal products; expert evaluation of advertising of medicinal products; informing the public on matters of quality and safety of medicinal products, etc.
During 2000–2001 pp., the issue of harmonizing the procedure for expert evaluation and registration of medicinal products in Ukraine with similar procedures in Europe was resolved.
The prepared documents contained a whole series of fundamentally new provisions, which allowed Ukraine to make a qualitative leap forward in the field of preclinical studies and clinical trials, expert evaluation, registration of medicinal products and post-registration surveillance. A requirement was introduced for mandatory notifications by healthcare institutions about adverse reactions to medicinal products and the creation of a vertical response system to these notifications.
With the assistance of the Center, international rules of good practices – GLP and GCP – were introduced in Ukraine: the currently effective orders of the Ministry of Health of Ukraine were prepared, which regulate the rules for conducting preclinical studies and clinical trials of medicinal products in accordance with the best world standards; a number of textbooks, manuals, and methodological recommendations on various aspects of preclinical studies and clinical trials of medicinal products were developed and published.
It was Academician O.V. Stefanov who created the modern European center, organized its work in accordance with modern requirements adopted in the developed countries of the world. The State Pharmacopoeia of Ukraine of the Ministry of Health of Ukraine was recognized as the best among the countries of the former USSR.
Among the employees, notable figures for the Center were Doctor of Medical Sciences, Professor Volodymyr Ivanovych Maltsev (1948-2008) and Doctor of Medical Sciences, Professor Oleksii Pavlovych Viktorov (1945-2011). Volodymyr Ivanovych initiated the permitting system for clinical trials of medicinal products in Ukraine as a new scientific and applied area of their development and study, and was the founder of a new area for Ukraine—the formulary system of providing medicinal products to healthcare institutions.
Maltsev V.I.Maltsev V.I., Doctor of Medical Sciences, Professor, Honored Doctor of Ukraine, Deputy Minister of Health of Ukraine and Minister of Health of Ukraine (1991-1994), Deputy Chairman of the Pharmacological Committee of the MoH of Ukraine (1994 – 1997), Head of the Clinical Trials Department of the State Pharmacological Center of the MoH of Ukraine (1997-2008).
With the direct participation of Maltsev V.I. and under the personal leadership of Viktorov O.P., in 1996 the pharmacovigilance system of Ukraine was initiated, and its fundamental principles were developed and implemented.
Viktorov O.P.Viktorov O.P., Doctor of Medical Sciences, Professor, Head of the Pharmacovigilance Department of the State Pharmacological Center of the Ministry of Health of Ukraine (1996-2008), Head of the Department of Clinical Pharmacology with the Laboratory of Functional Diagnostics of the National Scientific Center "Academician M.D. Strazhesko Institute of Cardiology of the National Academy of Medical Sciences of Ukraine".
The reference book is intended for physicians, pharmacists, students of pharmaceutical and medical educational institutions, and specialists engaged in the development and study of medicinal products. A scientific and methodological center for the preclinical study of medicinal products has been established, namely the Interdepartmental (MoH and Academy of Medical Sciences of Ukraine) Laboratory for the Preclinical Study of Medicinal Products. An important event was the publication in May 2007 of the electronic version of the "Reference Book of Medicinal Products of Ukraine". The Reference Book contains information on 11 336 domestic and imported medicinal products approved for use in medical practice in Ukraine. The State Expert Center of the Ministry of Health of Ukraine is actively developing new areas of activity related to the development and implementation of the State Formulary of Medicinal Products, the development of clinical guidelines and standards, unified clinical protocols of medical care, and monitoring of prices for medicinal products and medical devices.
Each section of the Compendium contains data on the composition of the medicinal product, pharmacological properties, mechanism of action, indications and contraindications for use, doses, adverse effects and other information necessary for rational pharmacotherapy.
Since the beginning of its work, the Center has established a number of its own independent scientific and expert commissions.
Great attention in the Center's activities has been and continues to be paid to its regional divisions, which were established on the basis of regional expert groups. The organization and activities of the Regional Divisions were founded on the goal of implementing in the regions the policy of the Ministry of Health of Ukraine and the Center in the field of development and rational use of medicinal products, and of providing physicians, healthcare professionals, manufacturing companies and the population of the region with objective scientific information about medicines.
For prompt informing of applicant companies, the WEB site of the State Pharmacological Center of the Ministry of Health of Ukraine was created, on which the regulatory and legal framework governing the process of state registration and re-registration of medicinal products in Ukraine was set out.
