RESOLUTION OF THE CABINET OF MINISTERS OF THE AZERBAIJAN REPUBLIC

of April 30, 2010 No. 83

About approval of Rules of carrying out scientific research, preclinical researches and clinical testing of medicines

For the purpose of ensuring execution of Item 1.3 of the Presidential decree of the Azerbaijan Republic of June 24, 2009 "About application of the Law of the Azerbaijan Republic of April 14, 2009 No. 794-IIIQD "About modification and amendments in the Law of the Azerbaijan Republic "About medicines" the Cabinet of Ministers of the Azerbaijan Republic decides No. 105:

1. Approve "Rules of carrying out scientific research, preclinical researches and clinical testing of medicines" it (is applied).

2. This resolution becomes effective from the date of signing.

Approved by the Resolution of the Cabinet of Ministers of the Azerbaijan Republic of April 30, 2010 No. 83

Rules of carrying out scientific research, preclinical researches and clinical testing of medicines

1. General provisions

1.1. These rules are prepared based on Item 1.3 of the Presidential decree of the Azerbaijan Republic of June 24, 2009 No. 105 "About application of the Law of the Azerbaijan Republic of April 14, 2009 No. 794-IIIQD "About modification and amendments in the Law of the Azerbaijan Republic "About medicines" and establish rules of carrying out scientific research, preclinical researches and clinical testing of medicines

1.2. Scientific research and preclinical researches of medicines are made in research establishments which list is approved by the Ministry of Health of the Azerbaijan Republic (further - the Ministry of Health). Requirements to organization (laboratory) in which scientific research and preclinical researches of medicines are conducted are established by the Ministry of Health. Control over respect by the customer and the program manager (researcher) of legal and ethical standards during the preclinical research of medicines is performed by the Ministry of Health or its authorized structure.

1.3. Requirements to carrying out scientific research and preclinical researches of the medicines made on animals, to researches on the complete or reduced programs over sick (volunteers) including to the researches on bioavailability (bioequivalence) made with involvement of people, and also the international multicenter clinical testing are established by these rules.

1.4. These rules extend to all types of clinical testing of medicines except for of not intervention researches and clinical testing of medicines which took place state registraitsyu in accordance with the established procedure in the Azerbaijan Republic according to their indications and dosages which are carried out without participation of the pharmaceutical companies.

1.5. Clinical testing of medicines are carried out based on permission of the Ministry of Health.

1.6. In case of insufficiency of specialized clinical bases and the contingent of patients necessary for carrying out clinical testing, and in other cases of impossibility of carrying out clinical testing, based on requirements of the corresponding legal acts of the World Health Organization (WHO) and other authoritative organizations (Centralized control Agency of the Countries of the European Unity over circulation of medicines (EMEA), Agency on control of drugs and foodstuff of the United States of America (FDA), the International conference on harmonization (ICH)) after conducting examination results of the clinical testing which are carried out in developed countries of the world can be accepted.

2. Terms and concepts

The terms used in these rules have the following values:

2.1. scientific research of medicine - determination of origins of various diseases, regularities of the mechanism of their development, development and check of efficiency of new methods of their prevention and treatment;

2.2. preclinical research - the complex biological, toxicological, chemical, physical and other pilot scientific research conducted for the purpose of studying of specific impact of the researched medicine per capita and/or its safety before its application in clinical practice;

2.3. the head of the research program - the main person responsible for quality of the conducted researches;

2.4. Multicenter clinical testing - testing of medicine which is performed more than in one treatment and prevention facility (more than one researcher) according to the single protocol.

2.5. Bioavailability - the speed and degree with which active ingredient or its active component is absorbed (is soaked up) from dosage form and possibility of its impact in the available place.

2.6. Bioequivalence - two medicines are considered bioequivalent if they are pharmaceutical equivalent or pharmaceutical alternative and if their bioavailability after introduction in the same molar dose are similar to such an extent that effects of these medicines in relation to efficiency and safety will be in fact identical.

2.7. The brochure of the researcher is abstract statement of clinical and preclinical data on the researched medicine which matter for its studying on the person.

2.8. Producer of medicine - the legal entity who performs production of medicines by industrial method taking into account requirements of the corresponding technical regulatory legal acts operating in the Azerbaijan Republic.

2.9. The researched medicine - the dosage form of active substance or placebo which did not undergo state registration which is studied or used for comparison in clinical testing, and also the registered medicine which is used according to the new indication which is not specified in the approved instruction for use or is studied for more information on its use or is made by new method.

2.10. The file of the researched medicine - information concerning quality of each researched medicine, including medicines of comparison and placebo, and also information concerning results of preclinical researches and prior clinical testing or clinical use of the researched medicine.

2.11. The researcher - the doctor who has adequate scientific preparation and experience of treatment of disease. The researcher bears responsibility for carrying out clinical testing of medicine in treatment and prevention facility. If testing in one treatment and prevention facility is carried out by group of persons, then researcher is the head of research group who can be called also responsible researcher.

2.12. consideration of materials of clinical testing is check and specialized assessment of materials of clinical testing of medicine for the purpose of preparation of motivated conclusions for decision making about carrying out clinical testing or refusal of their carrying out.

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