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

According to article 74 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system", I ORDER:

1. Approve the enclosed Rules of performing clinical trials and (or) testing pharmacological and medicines, products of medical appointment and medical equipment.

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of Health of the Republic of Kazakhstan 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.) provide official publication of this order after its state registration in the Ministry of Justice of the Republic of Kazakhstan.

4. Declare invalid the order of the Minister of Health of the Republic of Kazakhstan of February 14, 2005 No. 53 "About approval of the Instruction for performing clinical trials and (or) testing pharmacological and medicines in the Republic of Kazakhstan" (registered in the Register of state registration of regulatory legal acts for No. 3494).

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 its first official publication.

Approved by the Order of the Minister of Health of the Republic of Kazakhstan of November 19, 2009 No. 744

Rules of performing clinical trials and (or) testing pharmacological and medicines, products of medical appointment and medical equipment

1. General provisions

1. These rules of performing clinical trials and (or) testing pharmacological and medicines, products of medical appointment and medical equipment (further - clinical trials) in the Republic of Kazakhstan (further - Rules) determine the procedure for performing clinical trials in the Republic of Kazakhstan providing protection of the rights, safety and health protection of persons participating in researches and also reliability and accuracy of information obtained during clinical trial.

2. In these rules the following basic concepts are used:

1) audit - systematic, independent and documentary verification of documentation and activities of the parties involved in performing clinical research which is conducted 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;

2) bioavailability - the speed and degree with which active substance or its active part is soaked up from dosage form and becomes available in the place of its action;

3) bioequivalence - the comparative characteristic of two medicines under identical conditions which confirms their pharmaceutical and biological equivalence concerning efficiency and safety after use in identical molar doses;

4) the brochure of the researcher - abstract statement of results of preclinical and clinical studying of the researched medicine, products of medical appointment and medical equipment significant for its research on the person;

5) the reproduced medicine (generic) - the medicine identical to original medicine on structure and indicators of quality, safety and efficiency and arrived in the address after expiration of security documents on original medicine;

6) the second phase of clinical trials - research of the examinee of sample for the purpose of establishment of therapeutic efficiency and safety at examinees of the corresponding profile;

7) the customer of clinical trials - the physical person or legal entity which is the applicant of clinical trial, responsible for its organization, control and (or) financing;

8) individual registration form (further - IRF) - the printing and electronic document intended for introduction in it of information on each examinee provided by the protocol of clinical trial;

9) inspection of clinical trial - the procedure of official check by authorized body in the field of health care (further - authorized body) with involvement of specialists and experts of the state expert organization in the field of drug circulation, products of medical appointment and medical equipment (further - the expert organization) material resources (rooms, the equipment and equipment) and documents relating to clinical trial, for quality evaluation of performing clinical trial and the obtained data;

10) information for the examinee - the document describing common goals of research, risk and advantage of participation in it, and also procedures in which participation of the examinee will be required;

11) the informed consent - documentary drawn up voluntary consent of the examinee to participation in clinical trial after acquaintance with all its features, signed and dated the patient;

12) bioequivalence researches - one of types of clinical trials representing comparative studying of bioavailability for the purpose of establishment of pharmacokinetic equivalence between the tested and reference medicine;

13) the examinee - the patient or the healthy person who in voluntary procedure is taking part in clinical trial;

14) the doctor-researcher - the doctor who had training concerning performing clinical researches which conducts directly and are responsible for procedure for performing clinical trials in the medical organization. If the research is conducted by group of staff of clinical base, researcher (the responsible researcher) is the head of collective;

15) the researched medicine - ready medicine or placebo which is studied or used for control during clinical trials;

16) clinical base - the medical organization determined by authorized body, performing performing clinical trials based on the recommendation of the expert organization;

17) clinical trial pharmacological and medicine, products of medical appointment and medical equipment - the research with participation of the person as the examinee conducted for identification or confirmation clinical, pharmacological and (or) phracodynamic of effects of the researched sample and (or) identification of all collateral reactions to it and (or) for the purpose of studying of its absorption, distribution, biotransformation and removal for the purpose of establishment of its safety and efficiency;

18) the commission on questions of ethics - independent expert body which part specialists in the field of health care are, sciences, representatives of public organizations, performing protection of the rights, safety and wellbeing of examinees and researchers, and also ethical and moral legal treatment of materials of clinical trial;

19) the contractual research organization - physical person or legal entity which within the contract with the customer performs one or several its functions connected with performing clinical trial;

20) multicenter clinical trials - researches pharmacological and medicine, products of medical appointment and medical equipment which are performed in several clinical bases (more than one researcher) according to the single protocol;

21) the international multicenter clinical trial - the multicenter clinical trial conducted under the single protocol in two or more countries;

22) the monitor - the person designated by the customer, controlling performing clinical trial according to the protocol;

23) monitoring of clinical trial - control procedure for the course of clinical trial and ensuring its carrying out, data collection and representation of results of research according to the protocol, standard operational procedures, these rules;

24) unexpected side effect - collateral reaction (phenomenon), nature or degree of expressiveness of which does not answer the existing information provided in the brochure of the researcher;

25) sample for clinical trials - pharmacological and the medicine, product of medical appointment and medical equipment used in clinical trials;

26) limited clinical trials (according to the reduced program) - researches on the limited number of examinees;

27) the report on clinical trial - the results of clinical trial reported in writing and their analysis, according to requirements of these rules;

28) assessment of materials of clinical trial - check and consideration by the expert organization of materials of preclinical (not clinical) research and clinical trial of examinees of samples for the purpose of pronouncement of the recommendation of opportunity or refusal in performing clinical trial, approval of its results;

29) the patient - the physical person which is (being) the consumer of medical services;

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