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ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of April 2, 2018 No. 142

About approval of Rules of carrying out preclinical (not clinical) researches, clinical trials, clinical laboratory testing of medical products for diagnostics of in vitro, and also requirements to preclinical and clinical bases

(as amended of the Order of the Minister of Health of the Republic of Kazakhstan of 24.06.2019 No. KR DSM-96)

According to Item 2 of Article 72, Item 3 of Article 74 and 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" PRIKAZYVAYU:

1. Approve Rules of carrying out preclinical (not clinical) researches, clinical trials, clinical laboratory testing of medical products for diagnostics of in vitro, and also requirements to preclinical and clinical bases.

2. Recognize invalid some orders of the Ministry of Health of the Republic of Kazakhstan according to appendix 2 to this order.

3. To provide to department of science and human resources of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) within ten calendar days from the date of state registration of this order the direction it the copy in paper and electronic type in the Kazakh and Russian languages in the Republican state company on the right of economic maintaining "The republican center of legal information" for official publication and inclusion in Reference control bank of regulatory legal acts of the Republic of Kazakhstan;

3) within ten calendar days after state registration of this order the direction it the copy on official publication in periodic printing editions;

4) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

5) within ten working days after state registration of this order submission to Department of legal service of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2), 3) and 4) of this Item.

4. To impose control of execution of this order on the vice-Minister of Health of the Republic of Kazakhstan Aktayeva L. M.

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

Minister of Health of the Republic of Kazakhstan

E.Birtanov

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of April 2, 2018 No. 142

Rules of carrying out preclinical (not clinical) researches, clinical trials, clinical laboratory testing of medical products for diagnostics of in vitro, and also requirement to preclinical and clinical bases

Chapter 1. General provisions

1. Rules of carrying out preclinical (not clinical) researches, clinical trials, clinical laboratory testing of medical products for diagnostics of in vitro (further - Rules), and also requirements to preclinical and clinical bases are developed according to Item 2 of Article 72 and Item 3 of article 74 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" (further - the Code) and determine procedure for carrying out preclinical (not clinical) researches, clinical trials of medicines and medical products, clinical laboratory testing of medical products for diagnostics of in vitro, and also establish requirements to preclinical and clinical bases.

2. These rules extend on:

1) preclinical (not clinical) researches, medicines and research (testing) of assessment of biological effect of medical products;

2) clinical trials of medicines, medical products, clinical laboratory testing of medical products for diagnostics of in vitro.

3. In these rules the following terms and determinations are used:

1) the informed consent - the procedure of voluntary confirmation by the subject of research or its legal representative of consent to participation in specific research after receipt of information on all significant for adoption of the decision by it aspects of research;

2) unforeseen undesirable reaction - undesirable reaction, nature, severity or outcome of which do not correspond to information the existing instruction on medical application of medicine or the brochure of the researcher for the unregistered medicine;

3) biological equivalence (bioequivalence) - lack of significant distinctions on the speed and degree with which active ingredient or active part of molecule of active ingredient of pharmaceutical equivalents or pharmaceutical alternatives become available in the place of the action in case of introduction in identical molar dose in similar conditions in research with proper design;

4) bioequivalence research - comparative studying of bioavailability for the purpose of establishment of pharmacokinetic equivalence between the tested medicine and medicine of comparison;

5) bioethical examination - consideration of biomedical research and issue of the reasonable conclusion of the Commission on bioethics from line item of the ethical acceptability, safety for participants and feasibility of this research;

6) medicine - the means representing or containing the substance or combination of substances coming into contact with human body, intended for treatment, prevention of diseases of the person or recovery, correction or change of its physiological functions by means of pharmacological, immunological or metabolic impact or for diagnosis of diseases and condition of the person;

7) exception of the standard procedure of clinical trial of medicine - the procedure of the admission of the unregistered medicine to clinical application in exclusive procedure in one medical organization for individual indications;

8) the sponsor - physical person or legal entity, responsibility for its organization and (or) financing being the initiator of clinical trial and bearing;

9) the undesirable phenomenon - any adverse change in the state of health of the patient or the subject of clinical trial (testing) to which the medicinal (researched) medicine, irrespective of cause and effect relationship with its application was appointed;

10) undesirable reaction - the inadvertent, adverse reaction of organism connected using the medicinal (researched) medicine and assuming availability of possible interrelation using this medicinal (researched) medicine;

11) unfavorable event (incident) - any defect and (or) deterioration in characteristics or violation of functioning of medical product, either insufficiency or incorrectness of accompanying information (documentation) on the medical product, side effects or undesirable reaction which are not specified in the instruction for application or the operation manual which directly or indirectly brought or could lead to death or serious deterioration in the state of health of users or the third parties;

12) the individual registration card (further - IRK) - the document on the paper and/or electronic medium intended for introduction all to the transfer to the sponsor of information on each subject of research provided by the protocol and subject;

13) the researched medicine - the dosage form of active agent or placebo studied or used for control in clinical trial including the registered medicine if the method of its 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;

14) the head of research - person responsible for general performing not clinical trial of safety for health of the person and the environment;

15) the research center - the organization based on which the preclinical (not clinical) research, clinical trial of medicines, medical products, clinical laboratory testing of medical products for diagnostics of in vitro is conducted;

16) the researcher - 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 by the researcher (the chief researcher) is the head of group;

17) the brochure of the researcher - summary statement of results of clinical and preclinical (not clinical) studying of the researched medicine, significant for its research on the person;

18) not intervention research - research which is conducted after state registration of medicine and is appointed within medical practice according to the instruction on medical application;

19) intervention research - research with participation of the person as the subject of research with which the doctor-researcher based on the protocol of the intervention clinical trial corresponding to procedure for performing clinical trials appoints to subjects of research special intervention;

20) clinical base - the actual venue of clinical trial;

21) preclinical base - the organization which is the actual venue of preclinical (not clinical) research;

22) preclinical (not clinical) research - chemical, physical, biological, microbiological, pharmacological, toxicological and other pilot study or series of researches on studying of the researched substance (medicine) by application of scientific evaluation methods for the purpose of studying of specific action and (or) receipt of proofs of safety for health of the person;

23) clinical trial - the research with participation of the person as the subject conducted for identification or confirmation of safety and efficiency of means, methods and technologies of prevention, diagnostics and treatment of diseases;

24) the first phase of clinical trial - the first testing of medicine which is carried out on the healthy volunteers or patients having the corresponding disease when high toxicity of the researched medicine does carrying out research at healthy volunteers unethical, for the purpose of establishment of shipping, safety, availability of therapeutic action, pharmacokinetic and phracodynamic of characteristics;

25) the second phase of clinical trial - research for the purpose of efficiency evaluation and short-term safety of the researched medicine at patients with specific disease, and also the proof of clinical efficiency of medicine and determination of therapeutic level of dispensing when testing on group of patients;

26) the fourth phase of clinical trial - research of medicine which is performed after its registration and revenues to the market, for the purpose of confirmation of therapeutic efficiency, the strategy of its further use, and also for more information on range and frequency of side effects and interaction of the researched medicine with other medicines;

27) the third phase of clinical trial - the research conducted on big groups of patients of various age with various accompanying pathology, for the purpose of studying of all aspects of treatment, including indicator assessment risk/advantage;

28) the report on clinical trial - the document containing the description of clinical trial of therapeutic, preventive or diagnostic means with participation of the person as the subject uniting clinical and statistical descriptions, data presentation and their analysis; the remote effects, including undesirable reactions of the researched medicine, medical product;

29) the protocol of clinical trial (further - the protocol) - the document describing the purposes, design, methodology, statistical aspects and the organization of research;

30) auxiliary medicine - the registered medicine used for the purpose of clinical trial according to the protocol of clinical trial, but not as the researched medicine; the medicines which are not specified in the protocol of clinical trial do not belong to auxiliary medicines;

31) the serious undesirable phenomenon (further - SNYa) and (or) serious undesirable reaction (further - SNR) - undesirable reaction which leads to death poses threat for life, requires hospitalization of the patient or its prolongation, results in the resistant or expressed disability or disability, to congenital anomalies or malformations, requires medical intervention for prevention of development of the listed conditions;

32) general characteristic of medicine for medical application (further - OHLP) - the document containing information for health workers on safe and effective use of medicine for the purpose of the correct purpose of medicine and control of its application;

33) the medical organization - the organization of health care which main activities is delivery of health care;

34) Advisory council of the state expert organization (further - Advisory council) - the collegiate organ created in the state expert organization for consideration of matters of argument in results of examination, the bases (reasons) of issue of the negative conclusions on efficiency, safety and quality of medicines, medical products and acceptance of the final decision;

35) medicines of the advanced therapy (further - LPPT) - the medicines of medical application which are medicines of gene therapy, therapy by somatic cages, tkaneinzhenerny medicines or the combined medicines for the advanced therapy;

36) the combined medicines for the advanced therapy - medicines, for the advanced therapy, provided to combinations with medical product;

37) comparison medicine - the registered medicine or placebo used as control in clinical trial;

38) the Commission on assessment of materials of clinical trials of the expert organization - collegiate organ for decision making for the purpose of the direction of the recommendation in authorized body of clinical trial;

39) the expert organization - the state expert organization in the sphere of drug circulation, medical products;

40) standard operational procedures (further - SOP) - the detailed written instructions intended for achievement of uniformity when implementing certain activities;

41) the subject (the subject of research) - the physical person participating in clinical trial as a part of the group receiving the researched medicine or as a part of control group;

42) therapeutic equivalence - achievement of clinically comparable therapeutic effect in case of use of medicines for the same group of patients on the same indications";

43) the technical file - the technical documentation set on medical product including the description of medical product and its intended use, and also covering questions of designing, production and operation of medical product;

44) proper clinical practice of Good Clinical Practice (Goode the practician) (further - GCP klinikat) - the standard of planning, the organization, carrying out, monitoring, audit, documentation of clinical trials, and also the analysis and representation of their results serving as guarantee of reliability and accuracy obtained yielded and the provided results, and also providing protection of the rights, health and confidentiality of subjects of research;

45) tkaneinzhenerny medicine - medicine which contains or consists of the cages or fabrics subjected to engineering and has properties and also is applied or appointed to the person for the purpose of regeneration, reparation or replacement of tissue of the person;

46) protocol synopsis - summary of the protocol of clinical trial.

4. Preclinical (not clinical) researches, clinical trials, clinical laboratory testing of medical products for diagnostics of in vitro are conducted in case of simultaneous observance of the following requirements:

1) researches are directed to receipt of new scientific data and their implementation in practical health care;

2) protection of interests of the subject of research and confidentiality of its medical information are provided;

3) the consent of the subject of research or its legal representative to participation in research or use of its biological samples and medical information, including for filling of biobank in the scientific purposes is received;

4) intervention clinical trials are conducted with the permission of authorized body.

5. For the purpose of safety and protection of the rights of participants of medical researches when carrying out preclinical (not clinical), clinical, clinical laboratory testing of medical products for diagnostics of in vitro the Central and Local commissions are created.

The central commission is created under authorized body according to the order of the Minister of Health of the Republic of Kazakhstan of April 5, 2019 No. KR DSM - 20 "About approval of regulations on the Central commission on bioethics" (further - Regulations on the Commission) (it is registered in the Register of state registration of regulatory legal acts at No. 18480).

The local commissions are created under the medical organizations for independent assessment of the researches conducted on their base.

Chapter 2. Procedure carrying out preclinical (not clinical) researches

6. The sponsor chooses the research center for carrying out preclinical (not clinical) research.

7. Preclinical (not clinical) researches of medicines are conducted according to the Good laboratory practice Standard (Goode of laboratory the practician) (Further - GLP) approved by the order of the Minister of health and social development of the Republic of Kazakhstan of May 27, 2015 No. 392 "About approval proper pharmaceutical the practician" (it is registered in the Register of state registration of regulatory legal acts at No. 11506) (further - the Order No. 392).

Researches (testing) of assessment of biological effect of medical products are conducted according to ISO 10993, entering the List of standards as a result of which application on voluntary basis observance of compliance of medical products to General requirements of safety and efficiency of medical products is fully or partially provided, to requirements to their marking and operational documentation on them recommended by Board the Eurasian economic commission of September 04, 2017 to No. 17 (further - the recommendation of Board the Eurasian economic commission No. 17).

8. The preclinical (not clinical) research is conducted according to the approved plan of carrying out research with taking the minutes of this research and creation of the report which contains results of researches.

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