of September 6, 2024 No. 66
About modification of the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83
In compliance Articles 6, of 7, 10 and 12 Agreements on the single principles and rules of drug circulation within the Eurasian Economic Union of December 23, 2014, Items 81, the 83 and 96 appendices 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 Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83 "About approval of Rules of conducting pharmaceutical inspections" changes according to appendix.
2. This Decision becomes effective after 30 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 |
I. Petrishenko |
|
From the Republic of Kazakhstan |
S. Zhumangarin |
|
From the Kyrgyz Republic |
A. Kasymaliyev |
|
From the Russian Federation |
A. Overchuk |
Appendix
to the Decision of Council of the Eurasian economic commission of September 6, 2024 No. 66
1. In word preamble "Articles 7, 10 and 12" shall be replaced with words "Articles 6, of 7, 10 and 12", "Items 81 and 96" shall be replaced with words words "Items 81, 83 and 96".
2. Add Item 1 with the paragraph of the following content:
"Rules of conducting pharmaceutical inspections on compliance to requirements of Rules of proper clinical practice of the Eurasian Economic Union.".
3. Add with Rules of conducting pharmaceutical inspections on compliance to requirements of Rules of proper clinical practice of the Eurasian Economic Union of the following content:
"Are approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 83
1. These rules establish single procedure for carrying out by pharmaceutical inspectorate of pharmaceutical inspections on compliance to requirements of 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 (further respectively – inspections, Rules of clinical practice).
2. Inspection is carried out for the purpose of determination of compliance of clinical trials to requirements of Rules of clinical practice, including protection of the rights, safety and wellbeing of subjects of researches, ensuring reliability and the accuracy of the data received in clinical trial and also observance of ethical requirements to such researches.
3. Inspections are carried out by pharmaceutical inspectorate in the form of exit, remote and documentary inspections and checks.
4. Inspection includes conducting verification of documents, infrastructures, records, agreements on questions of quality assurance and any other sources which are regarded by authorized body as belonging to clinical trial and which can be located in the research center (the center of clinical trials, clinical center), on objects of the sponsor and (or) the contractual research organization or in other organizations requiring inspection. If conducting inspection of the clinical centers, laboratories or other objects participating in clinical trial is not required, according to the decision of authorized body on the basis the risk - the oriented approach is allowed conducting documentary inspections.
5. According to the solution of pharmaceutical inspectorate conducting pharmaceutical inspections with use of means of remote interaction (for example, by means of audio-or video conference) in the following cases is allowed:
a) origin threat, origin and liquidation of emergency situation and (or) emergence of threat of spread of the epidemic diseases constituting danger to people around, and also the diseases and defeats received as a result of impact of adverse chemical, biological, radiation factors;
b) emergence of force majeure circumstances or the parties of circumstances, independent of will, which pose threat of damnification of life and to health of pharmaceutical inspectors (further – inspectors) (for example, for political, medical or other reasons);
c) results of assessment of possibility of conducting inspection in this mode on basis risk - the oriented approach.
6. The inspection team in the activities is guided by the developed and implemented quality system of pharmaceutical inspectorate of state members of the Eurasian Economic Union (further – state members, the Union), according to the General requirements to the quality system of pharmaceutical inspectorates of state members of the Eurasian Economic Union approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 82 (further – General requirements to the quality system), approved by management of pharmaceutical inspectorate of the procedures determining procedure for planning, the organization and conducting inspections. The quality system of pharmaceutical inspectorate shall include the organizational structure, accurate processes and procedures (including standard operational procedures) observed by inspectors in case of accomplishment of the tasks, accurately formulated job responsibilities and responsibility of inspectors, requirements about continuous training, and also sufficient resources and mechanisms for elimination of discrepancies.
7. For the purpose of ensuring protection of confidential information, in particular personal data of subjects of the clinical trials concerning condition of their health, and also data which are trade secret, the inspectors and experts participating in conducting inspections shall observe requirements of the legislation of state members in the field of protection of the data which are trade secret and in the field of protection of know-how (know-how) (including international agreements). When processing personal data the inspectors and experts participating in conducting inspections shall observe requirements of the legislation of state members or the third countries in the field of protection of personal data.
8. During inspection inspectors shall take into account need of application risk - the oriented approach to planning and performing clinical trials.
9. These rules are applied to conducting the inspections concerning:
a) the clinical trials conducted within the Union including the research centers connected with such researches and located in the territories of the third countries;
b) the clinical trials specified in the statement for receipt of permission to performing clinical trial within the Union;
c) the clinical trials conducted in the third countries and specified in statements for registration of medicines within the Union.
10. Inspections are carried out:
a) before carrying out, during and upon completion of clinical trial;
b) within examination of the registration file of the medicine declared on registration;
c) as the subsequent measures after medicine registration implementation.
11. Inspections can be unplanned and planned. Planned inspections are carried out according to the plan of pharmaceutical inspectorate, including within 3 years from registration date of medicine according to the Rules of registration and examination of medicines for medical application approved by the Decision of Council of the Eurasian economic commission of November 3, 2016 No. 78 (further – Rules of registration and examination). Planning of inspections is allowed to be carried out according to the principles of risk management.
12. For the purposes of these rules concepts which mean the following are used:
"inspection" – stage of inspection during which the inspection team holds events according to the program of inspection;
"the inspected subject" – the organization (the research center, the center of clinical trials, clinical center, the contractual research organization) performing activities for the organization, carrying out or coordinating of clinical trials of medicines.
The concept "inspection" is applied in the value determined by Rules of clinical practice, the concepts "pharmaceutical inspectorate" and "pharmaceutical inspector" are applied in the values determined by General requirements to the quality system.
13. Inspectors shall have higher education in the field of medicine, pharmacy, pharmacology, toxicology or in other adjacent areas corresponding to the principles of proper clinical practice.
14. Inspectors shall receive the corresponding preparation, including experience of participation in inspections. Their needs for preparation necessary for maintenance or enhancement of their skills, shall be estimated regularly by service of quality assurance of pharmaceutical inspectorate according to requirements of the quality system of pharmaceutical inspectorate.
15. Inspectors shall know the principles and processes which are applied in case of development of medicines and performing clinical trials, and also provision of acts of bodies of the Union in the field of drug circulation and the legislation of state members in the part which is not settled by acts of bodies of the Union.
16. Inspectors shall be able to take out professional judgments of compliance of activities of the inspected subject to acts of bodies of the Union in the field of drug circulation and to the legislation of state members in the part which is not settled by acts of bodies of the Union and also shall be able to estimate reliability (quality and integrity) of data, their reliability and ethical requirements to performing clinical trials.
17. Inspectors shall understand procedures and technical methods of documentation of clinical data and works with them, and also the organization and regulation of health care systems in the corresponding state members and, when applicable, the third countries in which the research is conducted.
18. The education level and qualification of inspectors shall allow them to carry out assessment of risk degree for:
a) safety of subjects of research;
b) reliability and reliability of the obtained data.
19. Inspectors shall know applicable requirements of acts of bodies of the Union in the field of confidentiality and personal data protection and the legislation of state members in the part which is not settled by acts of bodies of the Union.
20. The pharmaceutical inspectorate shall keep documentation on qualification, experience and training of each inspector according to General requirements to the quality system.
21. The inspectors participating in conducting inspection shall not be under any influence capable to affect their impartiality or judgment. Inspectors shall not have conflict of interest. They shall be independent of the applicant on conducting inspection and (or) other subjects of inspection (including of the sponsor, researchers involved in clinical trial, persons financing clinical trial, any other party participating in performing clinical trial).
22. The candidacy of the member of inspection team can be rejected in the presence of information on possibility of conflict of interest.
23. Before conducting inspection each inspector signs the declaration on no conflict of interest when conducting this inspection.
24. Inspectors shall check observance of Rules of clinical practice, including observance of requirements of the approved protocol of clinical trial (including protection of the rights and wellbeing of subjects of researches, ensuring their safety), quality, integrity and the accuracy of the data received when performing clinical trial and also observance of ethical requirements and provisions of acts of bodies of the Union and the legislation of state members in the part which is not settled by acts of bodies of the Union.
25. By pharmaceutical inspectorates procedures of conducting inspection concerning at least following shall be developed and adopted:
involvement of experts for accomplishment of certain obligations if within inspection ownership of special knowledge is necessary;
the organizations of inspections in the territories of the third countries;
checks of observance of Rules of clinical practice, including methods of control of procedures of the organization of research and conditions of planning, carrying out, monitoring and documentation of data of clinical trial, and also the subsequent measures, such as verification of the analysis of the reasons of essential discrepancy of performing clinical trials to requirements of Rules of clinical practice and control of acceptance by the sponsor of the adjusting and warning actions.
26. The pharmaceutical inspectorate determines obligations of the involved experts.
27. Authorized bodies (pharmaceutical inspectorates) of state members perform interaction for development and enhancement of rules and approaches to conducting inspections. Such interaction can be performed in the form of joint inspections, the approved processes and procedures, and also by experience exchange and training of inspectors.
28. The Eurasian economic commission (further – the Commission) posts on the official site of the Union, developed together with authorized bodies (pharmaceutical inspectorates) of state members:
a) recommendations of the Commission on rules and approaches to conducting inspection;
b) recommendations of Expert committee on medicines concerning settlement of disagreements of authorized bodies in case of recognition of results of clinical trials and testing of medicines and holding joint inspections.
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