DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of August 1, 2025 No. 63

About modification of Rules of proper clinical practice of the Eurasian Economic Union

According to article 6 of the Agreement on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014 and Item 83 of appendix No. 1 to the Regulations of work of the Eurasian economic commission approved by the Decision of the Supreme Eurasian economic council of December 23, 2014 No. 98, Council of the Eurasian economic commission DECIDED:

1. Bring in the Rules of proper clinical practice of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 79, of change according to appendix.

2. This Decision becomes effective after 180 calendar days from the date of its official publication.

Members of council of the Eurasian economic commission: From the Republic of Armenia

M. Grigoryan

From the Republic of Belarus

N. Petkevich

From the Republic of Kazakhstan

S. Zhumangarin

From the Kyrgyz Republic

D. Amangeldiyev

From the Russian Federation

A. Overchuk

Appendix

to the Decision of Council of the Eurasian economic commission of August 1, 2025 No. 63

The changes made to Rules of proper clinical practice of the Eurasian Economic Union

1. Rules to state in the following edition:

"Are approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 79

(in edition of the Decision of Council of the Eurasian economic commission of August 1, 2025 No. 63)

Rules of proper clinical practice of the Eurasian Economic Union

I. General provisions

These rules represent the international ethical and scientific standard of planning and carrying out researches with participation of the person as the subject of researches, and also documentary registration and representation of results of such researches.

Observance of provisions of these rules serves as guarantee that the rights, safety and wellbeing of subjects of research are protected for society, accord with the principles underlain by the Helsinki declaration adopted on the XVIII General Assembly of the World Medical Association in 1964 and that these researches are reliable.

The purpose of these rules is establishment of single procedure for performing clinical trials (testing) of medicines that shall promote ensuring functioning of the total market of medicines within the Eurasian Economic Union (further – the Union), to mutual recognition of these researches by authorized bodies of state members of the Union (further – state members), and also to recognition of results of the researches conducted on customs area of the Union and beyond its limits.

The numbering used in the Section II of these rules corresponds to the numbering applied in the international edition of proper clinical practice regarding all subsections, except for subsection 1, in which concepts are located in alphabetical order.

These rules are prepared on the basis of ICH GCP – the Management on proper clinical practice which is the document E6 (R 2) of the International council on harmonization of technical requirements to pharmaceutical medicines for medical application.

Development of technologies and risk management processes opens new opportunities of increase in efficiency of carrying out researches of medicines, allows to be focused on the most significant aspects. Progress in area of documentation and representation of results of researches regarding transition from information on papers in format of electronic data facilitates implementation of modern approaches. For example, centralized monitoring can give more benefits and in the bigger number of researches now. These rules were added to promote implementation of advanced and more effective approaches to planning, carrying out, control, documentation and representation of results of researches when preserving ensuring protection of subjects of research and reliability of results of researches. To improve quality and efficiency of researches requirements to electronic records and the main documents were updated.

These rules are connected with acts of bodies of the Union in the field of performing clinical trials.

Considering importance of maintenance of acts of bodies of the Union in the field of drug circulation according to modern international standards, these rules were added on the basis of the last edition of the Management on proper clinical practice of ICH E6 (R 2).

These rules need to be followed when carrying out any researches of medicines which data are represented to authorized bodies (the expert organizations) of state members.

The principles established by these rules are applicable as well to other clinical trials which can exert impact on safety and wellbeing of the person acting as the subject of research.

These rules are subject to revision on regular basis taking into account experience of their application in state members, and also in case of change of the international standards of carrying out researches (with introduction of necessary changes).

II. Main part

1. Determinations

For the purposes of these rules concepts which mean the following are used:

1.1. "audit" (audit) – systematic and independent check belonging to research of activities and documentation, carried out for confirmation of conformity of these activities, and also procedures of collection, the analysis and data presentation to the protocol of clinical trial, standard operational procedures of the sponsor ought to clinical practice and applicable requirements;

1.2. "wellbeing of subjects of research (patients)" (well-being (of the trial subjects (patients))) – physical and mental health of the subjects participating in research;

1.3. "the brochure of the researcher" (investigator "s brochure) – summary statement of the clinical and preclinical data on the researched medicine relating to its research with participation of the person as the subject of research;

1.4. "validation of the computerized systems" (validation of computerized systems) – process of establishment and documentation of the fact testimonial of the fact that requirements imposed to the computerized system by the user are constantly observed from the moment of designing to conclusion of the computerized system from operation or transition to the new computerized system. Approach to validation of the computerized systems shall be based on risks assessment which considers purpose of the computerized system and capability of this system to influence protection of subjects and reliability of results of research;

1.5. "design of research" (study design) – the general plan of research, the description of method of carrying out research depending on selection and forming of groups of subjects of research, masking of data;

1.6. "agreement" (contract) – the dated and signed agreement between two or more parties which establishes the arrangements concerning distribution of amount of works and obligations when carrying out research and also in need of financial questions. The protocol of clinical trial shall form basis of the agreement;

1.7. "preclinical researches" (nonclinical study)" – the biomedical researches conducted without participation of the person as the subject researches;

1.8. "documentary trace" (audit trail) – documentation allowing to recover the course of events;

1.9. "documentation" (documentation) – all records in any form (including records on paper, electronic, magnetic or optical media, skanogramma, x-ray pictures, electrocardiograms, etc.) which describe or register methods, the organization and (or) results of research, and also factors influencing research and the taken measures;

1.10. "verified copy" (certified copy) – the copy (irrespective of carrier type) original record which as it was confirmed (for example, the dated signature or validirovanny process of creation of the copy), contains the same information, including data which describe context, content and structure, as original record;

1.11. "the conclusion of independent ethical committee (council on ethics, the commission on questions of ethics)" (opinion (in relation to Independent Ethics Committee (Ethical Council))) – the document in writing which contains the conclusion and (or) recommendations of independent ethical committee concerning participation of the person in research;

1.12. "legal representative" (legally acceptable representative)" – physical person or legal entity or other person of law having by law the right to agree to participation in clinical trial on behalf of the potential subject of research;

1.13. "identification code of the subject" (subject identification code) – the unique code assigned by the researcher for each subject of research for ensuring confidentiality of its personal data and used instead of name of the subject of research in reports on the undesirable phenomena and (or) other data relating to research;

1.14. "the individual registration card", "IRK" (Case Report Form, CRF) – the document on the paper, electronic or optical medium intended for introduction all to the transfer to the sponsor of information on each subject of research provided by the protocol of clinical trial and subject;

1.15. "inspection (check)" (inspection) – the action of authorized body consisting in conducting official check of documents, infrastructures, records, security agreements of quality and any other sources which are regarded by authorized body as belonging to research and which can be located in the research center, on objects of the sponsor and (or) the contractual research organization or in other organizations which, according to authorized body, require inspection;

1.16. "informed consent" (informed consent) – process of voluntary confirmation by the subject of the consent to participation in specific research after receipt of information on all significant for adoption of the decision by it aspects of research. The informed consent is documented by means of signing and dating of form of the informed consent;

1.17. "researcher" (investigator) – the physical person who is responsible for carrying out research in the research center. In case of carrying out research in the research center group of persons, researcher (the chief researcher) is the head of group;

1.18. "researcher-coordinator" (coordinating investigator) – the researcher who is responsible for coordination of activities of researchers of all research centers participating in multicenter clinical trial;

1.19. "the researcher (the medical organization) of" (investigator (institution))" – the researcher and (or) the organization (depending on applicable normative requirements);

1.20. "the research center" (trial site) – the actual venue of research;

1.21. "the researched medicine" (investigational medicinal product) – medicine which in research is subjected to test or is applied to comparison including placebo, including the registered medicine (if its method of application differs from approved, and also in case of its use according to the new indication or for more information according to the approved indication);

1.22. "clinical trial" (clinical trial) – any research conducted with participation of the person as the subject for identification or confirmation of clinical and (or) pharmacological effects of the researched medicines, and (or) identification of undesirable reactions to the researched medicines, and (or) studying of their absorption, distribution, metabolism and removal from human body for the purpose of assessment of their safety and (or) efficiency;

1.23. "the contractual research organization" (contract research organization, CRO) – physical person or the organization (commercial, research or other) which within the contract with the sponsor carries out one or more of its obligations and functions connected with performing clinical trial;

1.24. "quality control" (quality control, QC)" – the methods and measures which are part of system of quality assurance and used for check of compliance of the procedures performed when carrying out research to qualifying standards to their quality;

1.25. "confidentiality" (confidentiality) – preserving unknown to unauthorized persons of information belonging to the sponsor or information allowing to identify the subject of research;

1.26. "coordinating committee" (coordinating committee) – committee which can be organized by the sponsor for coordination of performing multicenter clinical trial;

1.27. "the medical organization" (institution (medical)) – the organization of health care (regardless of its form of business) in which clinical trial is conducted;

1.28. "multicenter clinical trial" (multicentre trial) – the clinical trial conducted under the single protocol more than in 1 research center and more than 1 researcher;

1.29. "monitoring" (monitoring) – the activities consisting in control of the course of clinical trial, ensuring its carrying out, data collection and representation of results according to the protocol of clinical trial, standard operational procedures, proper clinical practice and applicable requirements;

1.30. "proper clinical practice" (Good Clinical Practice; GCP) – the code of ethical and scientific requirements to planning, carrying out, realization, monitoring, audit, documentation, the analysis and representation of results of the clinical trials providing protection of the rights, safety and wellbeing of subjects of research and obtaining within clinical trial of reliable and reliable data;

1.31. "undesirable reaction" (adverse reaction) – rather preregistration clinical use of new medicine or its application according to new indications, especially, if therapeutic doses are definitely not established – all negative reactions connected using any dose of medicine. At the same time the term "connected using medicine" means that there is at least the minimum possibility of availability of cause and effect relationship between medicine and the undesirable phenomenon, that is the interrelation is not excluded. For the registered medicines undesirable reaction is understood as any negative reaction connected using medicine in the regular doses used for prevention, diagnostics or treatment of diseases and also for change of physiological functions;

1.32. "the undesirable phenomenon" (adverse event) – any adverse change in the state of health of the patient or the subject of research to which medicine, irrespective of cause and effect relationship with its application is injected. The undesirable phenomenon can represent any adverse and inadvertent change (for example, variation of laboratory indicator from regulation), symptom or disease which time of origin does not exclude cause and effect relationship using medicine (regardless of availability or lack of interrelation using medicine);

1.33. "independent committee on monitoring of data", "NKMD" (Independent Data-Monitoring Committee, IDMC (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)) – independent committee which can be formed at the initiative of the sponsor for periodic consideration of the course of clinical trial, this on safety and (or) key parameters of efficiency, and also for development of recommendations for the sponsor of feasibility of continuation, the termination of research or entering of changes into it;

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