DECISION OF COUNCIL OF THE EURASIAN ECONOMIC COMMISSION

of February 12, 2016 No. 29

About Rules of carrying out clinical and clinical laboratory testing (researches) of medical products

According to  Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, items 4 and the 5th article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, Items 105 and 106 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, and the Decision of the Supreme Eurasian economic council of December 23, 2014 "About implementation of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union" Council of the Eurasian economic commission solved No. 109:

1. Approve the enclosed Rules of carrying out clinical and clinical laboratory testing (researches) of medical products.

2. Determine that for medical products of classes of potential risk of use 3, 2b and the implanted medical products (except for medical products for diagnosis of in vitro and the software which is medical product) clinical testing (researches) for the purpose of registration if it is not proved that clinical performance and safety of the declared medical product can be confirmed with different way, shall be carried out in the form of multicenter testing (researches) and correspond to one of the following conditions:

a) clinical testing (researches) are carried out according to the legislation of state members of the Eurasian Economic Union and in their territories till January 1, 2022 (by date of the last visit of the last patient or subject of testing (research)) or continued to be carried out as of 1 yanvarya2022 (in case of complete set of patients);

b) clinical testing (researches) are carried out in the territories of the states which are not members of the Eurasian Economic Union till January 1, 2022 (by date of the last visit of the last patient or subject of testing (research)) or continued to be carried out as of January 1, 2022 (in case of complete set of patients) according to recommendations of the International forum of regulators of medical products (IMDRF);

c) clinical testing (researches) initiated after January 1, 2022 are carried out according to the right of the Eurasian Economic Union, at the same time one of clinical testing (researches) is carried out in one of state members of the Eurasian Economic Union.

3. This Decision becomes effective after 10 calendar days from the effective date of the Protocol signed on December 2, 2015 on accession of the Republic of Armenia to the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014, but not earlier than after 10 calendar days from the date of official publication of this Decision.

Approved by the Decision of Council of the Eurasian economic commission of February 12, 2016 No. 29

Rules of carrying out clinical and clinical laboratory testing (researches) of medical products

I. General provisions

1. These rules are developed according to Item 2 of article 31 of the Agreement on the Eurasian Economic Union of May 29, 2014, items 4 and the 5th article 4 of the Agreement on the single principles and rules of the address of medical products (products of medical prescription and medical equipment) within the Eurasian Economic Union of December 23, 2014 and establish within the Eurasian Economic Union (further – the Union) rules of carrying out clinical and clinical laboratory testing (researches) of medical products.

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

"anolyte" – test component with measurable property;

"analytical efficiency of medical product for diagnosis of in vitro" – capability of medical product for diagnosis of in vitro to reveal presence or to determine content of specific anolyte in biological test;

"biological reference population" – homogeneous population of the individuals who are in well certain state of health or disease;

"the brochure of the researcher" – summary statement of the up-to-date clinical and not clinical information about the examinee (researched) medical product relating to clinical testing (research) or clinical laboratory testing (research) (when performing intervention clinical trial of efficiency);

"the chief researcher" – the qualified person responsible for carrying out clinical or clinical laboratory testing (research). If testing (research) is carried out by team of researchers, the head of this team is the chief researcher;

"double blind method" – the procedure of clinical testing (researches) in which the subjects of testing (researches) and researchers participating in obtaining and processing of primary data are not informed on the actual use to subjects of testing (researches) of impact of medical product;

"design of clinical testing (research)" – methodology of carrying out clinical testing (research) with participation of the person as the subject of testing (research) by means of which it is planned to obtain statistically mathematical evidences of clinical safety and efficiency of the examinee (researched) medical product, including use of control groups of subjects of testing (research), and (or) distribution of subjects of testing (researches) on groups in a random way, and (or) use of unary or double blind method, and also the choice of the main and additional final points;

"additional final point" – the indicator (indicators) used for check of additional hypothesis of clinical testing (research);

"legal representative" – physical person or legal entity which according to the legislation of state member of the Union has the right to give the informed consent on participation in clinical or clinical laboratory (when performing intervention clinical trial of efficiency) testing (research) on behalf of the potential subject of testing (research);

"applicant" – the producer of medical product or its authorized representative;

"the individual registration card" – the document intended for entering into it by all provided program of testing (research) of information on each subject of testing (research);

"intervention clinical trial of efficiency" – research of clinical performance of medical product for diagnosis of in vitro which results influence decisions on maintaining the patient and (or) are used under management of treatment for goal achievement of clinical trial;

"informed consent" – the written instrument in which the subject of testing (research) or its legal representative confirms voluntary consent to participation in clinical or clinical laboratory (when performing intervention clinical trials of efficiency) testing (researches) based on the complete information provided to it about clinical or clinical laboratory testing (research);

"the ispytuyemy (researched) medical product" – medical product which during clinical testing (research) or clinical laboratory testing (researches) for medical products for diagnosis of in vitro is estimated regarding safety and (or) efficiency;

"researcher" – the team member of the researchers appointed by the chief researcher for implementation of the main procedures connected with clinical or clinical laboratory testing (research), or for decision making, connected with clinical or clinical laboratory testing (research), and submitting to the chief researcher;

"clinical laboratory testing (researches) of medical product for diagnosis of in vitro" – systematic testing (researches) of analytical characteristics and where it is applicable, clinical performance, carried out for the purpose of establishment or confirmation of conformity of medical product for diagnosis of in vitro to the appointment established by the producer;

"clinical performance of medical product for diagnosis of in vitro" – capability of medical product for diagnosis of in vitro to show the results correlating with specific clinical or physiological condition in target population in case of its use by the intended user;

"clinical data" – the data on safety and (or) efficiency received in case of clinical use of medical product. Clinical data can be obtained by search in scientific literature of data on medical product, from experience of clinical use of medical product, as a result of clinical or clinical laboratory testing (researches), by means of use of several of the specified methods or otherwise. Clinical data are also the data on safety and (or) efficiency received in case of clinical use of medical products which equivalence to the considered medical product can be proved;

"the clinical proof of efficiency and safety of medical product" – set of the clinical data confirming clinical performance and safety of medical product in case of its proper use, established by the producer, and their assessment;

"the clinical proof of efficiency and safety of medical product for diagnosis of in vitro" – data set, confirming scientific justification of anolyte, analytical efficiency and clinical performance of medical product for diagnosis of in vitro in case of its proper use, established by the producer, and their assessment;

"clinical testing (research) of medical product" – any testing (research) with participation of the person as the subject of testing (research) conducted for the purpose of studying of safety and (or) efficiency of the examinee (researched) medical product;

"committee on ethics" – independent expert body which is effective according to these rules and the legislation of state member of the Union and considers questions of providing the rights, safety and health protection of subjects of testing (researches);

"control medical product" – the product used in clinical testing (research) for comparison with the examinee (researched) medical product;

"coordinator-researcher" – the researcher appointed the applicant and who is responsible for coordination of work during multicenter clinical (clinical laboratory) testing (research);

"the medical organization (clinical center)" – the organization acting as the research center when carrying out clinical (clinical laboratory) testing (researches);

"multicenter testing (research)" – clinical (clinical laboratory) testing (research) which is carried out in two and more medical organizations (clinical centers) for the single program of testing (research);

"monitoring of clinical (clinical laboratory) testing (research)" – the activities connected with observation of the course of clinical (clinical laboratory) testing (research) for check that this the carried-out testing (research) register the report on monitoring is created according to the program of testing (research), documentary procedures and these rules;

"scientific justification of anolyte" – communication of anolyte with clinical or physiological condition of human body;

"unary blind method" – the procedure of clinical testing (researches) in which subjects of testing (researches) are not informed on the actual use of impact of medical product to them;

"the main final point" – the indicator (indicators) used for check of main hypothesis of clinical testing (research);

"the report on clinical laboratory testing (research) of medical product" – the written description of clinical laboratory testing (research) of medical product with use of the tests and samples including received by genetically engineered method, combining clinical laboratory and statistical descriptions, data presentation and their analysis in the established form;

"the report on clinical testing (research) of medical product" – the written description of clinical testing (research) of medical product with participation of the person as the subject of testing (research) combining clinical and statistical descriptions, data presentation and their analysis in the established form;

"primary data" – any information in the form of original records or verified copies of original records about the clinical facts, observations and other events during clinical (clinical laboratory) testing (researches), necessary for monitoring and assessment of results of clinical (clinical laboratory) testing (researches);

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