The Public Enterprise “State Pharmacological Center” of the Ministry of Health of Ukraine is a specialized expert institution authorized by the Ministry of Health of Ukraine (hereinafter –  MoH) to register and control circulation of medicinal products as per Law of Ukraine “On Medicines”. The center has been founded on the state property, governed by MoH and formed through reorganizing State Scientific and Expert Center of Medicinal Products (order MoH of 15.02.2000 № 23) and is its legal successor as per legislation of Ukraine. The order MoH of 10.07.2008 № 149-0 approved the Statute of PE “State Pharmacological Center” according to which the Center’s key functions are as follows:

• Expert evaluation of materials related to development, production (manufacture), pre-clinical study, clinical trials of medicinal products; regulatory and analytical support including experimental validation or additional testing as well as inspections of manufacturing conditions of medicinal products submitted for state registration, settings, institutions, which perform pre-clinical study and clinical trials of medicinal products, including their attestation in order to make conclusions on the possibility to conduct state registration (re-registration) of medicinal products, as well as expert evaluation of all changes proposed for introduction in the registration documents during validity period of the registration certificate.

• Development and submission to the Ministry of Health for approval of draft regulations on requirements to entities which develop and test medicinal products, materials of pre-clinical study and clinical trials of medicinal products, as well as procedure for conducting expert evaluation of these materials, pharmacopoeial articles or materials on methods for quality control of medicinal products, samples of medicinal products and their packaging, standards and requirements, including those pertinent to circulation of medicinal products, etc. which approval and establishing are within the MoH‘s jurisdiction with due consideration of requirements to the registration documents; adaptation of the above requirements to the European Union standards.

• Expert evaluation of materials pertinent to development, pre-clinical study of medicinal products aimed at their recommendation for clinical trials.

• Inspection of pre-clinical study and clinical trial sites, and manufacturing site of medicinal products, audit of their study/trial and manufacture.

• Arrangements for specifying laboratories and settings, etc. involved by the Center in its activity pertinent to pre-clinical studies and clinical trials, quality control, validation of (testing) methods for analysis of quality of medicinal products and their production.

• Preparation, examination and recommendations for MoH’s approval of regulatory documents concerning requirements to development, production of test samples, conduct of pre-clinical studies and clinical trials of medicinal products, as well as instructions for their medical use.

• Pharmacovigilance over medicinal products and adverse reactions/effects of medicinal products registered in Ukraine (organization and conduct of pharmacovigilance) and issuance of proposals to MoH about procedure for conducting this activity, and prohibition / suspension of using medicinal products.

• Post-registration surveillance over medicinal products registered in Ukraine in collaboration with the State Inspectorate for Quality Control of Medicinal Products pertinent to their quality and issuance of proposals to MoH on prohibition / suspension of their use.

• Expert evaluation of materials about active substances, excipients used in the manufacture of medicinal products and issuance of recommendations to MoH concerning the possibility of their use and registration.

• Substantiation of the priority developments of new medicinal products and prognosis for their need in Ukraine.

• Drawing up and submitting the Lists of OTC medicinal products for MoH’s approval.

• Substantiation of the possibility to import to Ukraine unregistered medicinal products and to permit their use in cases envisaged by legislation.

• Participation in compiling the State Register of Medicinal Products of Ukraine.

• Studying international experience regarding registration and expert evaluation of materials pertinent to medicinal products, participation in organization and holding international symposia, conferences, workshops, etc.

• Providing printing, computer, transport, information, counselling services, as well as translations of texts into foreign languages for legal entities and physical persons.

• Publishing, duplication, issuing and realization (sale) of various sorts of documentation, printing activity, organization of methodological textbook publishing, including editions on electronic carriers, which are aimed at disease prevention, promotion of healthy life-style, counselling services with recommendations (oral, in writing or in electronic form) etc.

• Scientific and practical, methodological, organizational and coordinating activity concerning development, introduction and use of new medicines, medical treatment technologies with application of materials (products) of human or animal origin, medical treatment with monoclonal, chimeric antibodies, hemopoietic stem cell transfusion methods, etc. Setting up appropriate laboratories, trial sites, data bases, registers, etc. which ensure the Center’s activity.

• Elaboration of recommendations for using research results in practice.

• Study and systematization of world science achievements in chemistry, pharmaceutics, pharmacology and toxicology, technologies, development, information bank formation, development of new IT and expert systems.

• Collection, systematization, generalization and analysis of information materials about adverse reactions to medicinal products, development of recommendations on their further use in medical practice.

• Post-graduate training of specialists in clinical pharmacology, pharmaceutics and pharmacovigilance.

• Research, consultations and taking measures for development and functioning of health care system of Ukraine, logistic support of such measures.

• Methodical and counselling activity referring to pre-clinical studies and clinical trials, pharmacovigilance, expert evaluation and registration of medicinal products.