ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of November 12, 2009 No. 697

About approval of Rules of carrying out medicobiological experiments, preclinical (not clinical) and clinical trials

For the purpose of implementation of article 180 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", PRIKAZYVAYU:

1. Approve the enclosed Rules of carrying out medicobiological experiments, preclinical (not clinical) and clinical trials.

2. To department of science and human resources of the Ministry of Health of the Republic of Kazakhstan (Hamzina N. K.) provide in accordance with the established procedure state registration of this order in the Ministry of Justice of the Republic of Kazakhstan.

3. To department of administrative and legal work of the Ministry of Health of the Republic of Kazakhstan (Bismildin F. B.) after state registration of this order to provide in the procedure established by the legislation official publication in mass media.

4. Declare invalid the order of the Minister of Health of the Republic of Kazakhstan of July 25, 2007 No. 442 "About approval of Rules of carrying out preclinical researches, medicobiological experiments and clinical testing in the Republic of Kazakhstan" (registered in the Register of state registration of regulatory legal acts for No. 4894, No. 140 published in "The legal newspaper" of September 13, 2007 (1343)).

5. To impose control of execution of this order on the vice-Minister of Health of the Republic of Kazakhstan Birtanov E. A.

6. This order becomes effective after ten calendar days after day of its official publication.

Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of November 12, 2009 No. 697

Rules of carrying out medicobiological experiments, preclinical (not clinical) and clinical trials

1. General provisions

1. These rules of carrying out medicobiological experiments, preclinical (not clinical) and clinical trials (further - Rules) are developed according to Item 11 of article 180 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" for the purpose of creation of single requirements to planning, carrying out, documentary registration and control of medicobiological experiments, preclinical (not clinical) and clinical trials of examinees of the methods and (or) means (further - experiment and (or) research) designed to guarantee protection of the rights, safety and health protection of persons participating in researches and also to provide reliability and accuracy received during the experiment and (or) research of information.

These rules extend to subjects of health care of the Republic of Kazakhstan.

2. These rules extend to all types of medicobiological experiments, the preclinical (not clinical) and clinical trials including which are carried out within:

1) dissertation researches,

2) republican target scientific programs,

3) the scientific programs and projects financed by domestic and foreign grantors

4) other forms of financing of scientific research.

Preclinical (not clinical) researches of biologically active agents are performed according to the Order of the Minister of Health of the Republic of Kazakhstan of November 19, 2009 No. 745 "About approval of Rules of carrying out preclinical (not clinical) researches of biologically active agents", registered in the Register of state registration of regulatory legal acts No. 5914.

Clinical trials and (or) testing pharmacological and medicines, products of medical appointment and medical equipment are performed according to the Order of the Minister of Health of the Republic of Kazakhstan of November 19, 2009 No. 744 "About approval of Rules of performing clinical trials and (or) testing pharmacological and medicines, products of medical appointment and medical equipment", registered in the Register of state registration of regulatory legal acts No. 5924.

3. All medicobiological experiments, preclinical (not clinical) and clinical trials in the territory of the Republic of Kazakhstan are conducted according to the international and national ethical standards and proper practicians of carrying out biomedical researches.

4. In these rules the following concepts are used:

1) audit of clinical trial of examinees of methods and (or) means - systematic, independent and documentary verification of documentation and activities of the parties involved in performing clinical trial of examinees of methods and (or) means which is performed by experts, independent of clinical trial and the research center, for confirmation of the fact of implementation of these activities, and also for assessment of conformity of procedures of collection, processing and data presentation, to requirements of the protocol of clinical trial, standard operational procedures, proper clinical practice (GCP) and normative requirements;

2) vivarium - it is experimental - the biological clinic which is scientific and auxiliary division of the research center and created for content, and in necessary cases for cultivation of the laboratory animals used in experiments and (or) researches;

3) the scientific and technical program of research - carrying out specific scientific research on the conditions provided by the contract between the customer and the researcher;

4) authorized body in the field of health care (further - authorized body) - the state body performing management in the field of protection of public health, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation, products of medical appointment and medical equipment, control of quality of medical services;

5) the volunteer - the healthy volunteer who signed the informed consent on participation in research;

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