ORDER OF THE MINISTRY OF HEALTH OF UKRAINE

of September 23, 2009 No. 690

About approval of the Procedure for carrying out clinical testing of medicines and examinations of materials of clinical testing and Standard regulations on the commissions on questions of ethics

According to Articles 7, 8 Laws of Ukraine "About medicines", the Directive of the European Parliament and Council 2001/20/EU "About approach of the laws, bylaws and administrative provisions of state members concerning introduction of proper clinical practice when carrying out clinical testing of medicines for application by the person" of April 4, 2001 (with changes), and also for the purpose of achievement of harmonization with the international rules of carrying out clinical testing of medicines ORDER:

1. Approve the Procedure for carrying out clinical testing of medicines and examination of materials of clinical testing which is applied.

2. Approve Standard regulations on the commissions on questions of ethics.

3. Recognize invalid the order of the Ministry of Health of Ukraine of February 13, 2006 as No. 66 "About approval of the Procedure for carrying out clinical testing of medicines and examinations of materials of clinical testing and Standard regulations on the commission on questions of ethics", the order of the Ministry of Health of Ukraine registered in the Ministry of Justice of Ukraine on March 10, 2006 for No. 252/12126, of May 17, 2007 No. 245 "About approval of the Procedure for determination of specialized treatment and prevention facilities in which clinical testing of medicines can be carried out", registered in the Ministry of Justice of Ukraine on August 17, 2007 for No. 950/14217, and the order of the Ministry of Health of Ukraine of August 11, 2006 No. 560 "About approval of the List of treatment and prevention facilities in which clinical testing of medicines can be carried out".

4. To provide to the director of the department of regulatory policy in the field of drug circulation and products in health care system Yu.B.Konstantinov in accordance with the established procedure state registration of this order in the Ministry of Justice of Ukraine.

5. To impose control over the implementation of the order on the deputy minister Z.M.Mytnik.

6. The order becomes effective from the date of its official publication.

Approved by the Order of the Ministry of Health of Ukraine of September 23, 2009, No. 690

Procedure for carrying out clinical testing of medicines and examination of materials of clinical testing

І. General provisions

1.1. This Procedure is developed according to Articles 7, 8 Laws of Ukraine "About medicines", the Law of Ukraine "About personal data protection" taking into account requirements of Directives 2001/20/EU of the European parliament and Council of April 04, 2001 about approach of the laws, bylaws and administrative provisions of the state members concerning implementation of proper clinical practice when carrying out clinical testing of medicines for use by the person, 2001/83/EU of November 06, 2001 about the Code of community concerning the medicines intended for application by the person (appendix I, part IV (medicines for the advanced therapy)), Regulations (EU) No. 536/2014 of the European parliament and Council of April 16, 2014 about clinical testing of medicines for use by the person and about cancellation of the Directive 2001/20/EU, Regulations (EU) No. 1901/2006 of the European parliament and Council of December 12, 2006 about medicines for pediatric use and modification of Regulations (EEC) No. 1768/92, of the Directive 2001/20/EU, the Directive 2001/83/EU and Regulations (EU) the No. 726/2004, Regulations (EU) No. 1902/2006 of the European parliament and Council of December 20, 2006 about modification of Regulations 1901/2006 concerning medicines for pediatric use, Regulations (EU) No. 1394/2007 of the European parliament and Council of November 13, 2007 about medicines of the advanced therapy and modification of the Directive 2001/83/EU and the Regulations (EU) the No. 726/2004, Directive of the Commission 2005/28/EU of April 08, 2005 establishing the principles and detailed instructions for proper clinical practice concerning the researched drugs for use by the person and also requirements to permission to production or import of such products, The directive 2004/23/EU of the European parliament and Council of March 31, 2004 about establishment of the quality standards and safety for donorship, obtaining, testing, processing, preserving, storage and distribution of fabrics and cells of the person, the management on proper clinical practice concerning medicines of the advanced therapy of C (2019) the 7140th final version of October 10 2019, ICHGCP, ICHGLR, GTR/SGTP, the international ethical principles of biomedical researches with participation of the person and the ethical code of the doctor.

1.2. This Procedure establishes the main requirements to carrying out clinical testing in Ukraine of medicines, including medicines of the advanced therapy (biological origin) which include medicines of gene therapy, somatic cellular therapy, fabric engineering; the combined medicines including as component of fabric and/or cage, and one or several medical products which can be carried out with participation of patients (healthy volunteers) according to the complete or reduced program, including before testing of bioavailability/bioequivalence, the international multicenter clinical testing.

1.3. This Procedure extends to all types of clinical testing of medicines, including medicines of the advanced therapy, except for not intervention researches.

This Procedure does not extend to clinical testing:

whole blood of the person;

the transplants which are minimum processed, and intended for accomplishment of the same function (functions) in organism of the recipient as at the donor (homological use);

not changed, considering the biological characteristics, haemo poetic trunk cages / клетки-предшественники from umbilical blood, peripheral blood or marrow, applied to forming and replenishment of limfogematopoetichesky system.

The activities connected with transplantation of haemo poetic trunk cages / клеток-предшественников are performed according to the Law of Ukraine "About application of transplantation of anatomic materials to the person" and procedure for obtaining and provision of haematopoietic stem cells and exchange of information of rather available anatomic materials of the person intended for transplantation, the Cabinet of Ministers of Ukraine approved by the resolution of March 25, 2020 to No. 257.

1.4. Conducting examination of materials of clinical testing, and also carrying out clinical audit of clinical testing of medicines and medicines of the advanced therapy is assigned to the state company "State Expert Centre of the Ministry of Health of Ukraine" (further - the Center).

1.5. At the request of the applicant the Center free of charge provides consultations concerning quality of planning and carrying out clinical testing of medicines, including medicines of the advanced therapy, according to regulatory legal acts and rules of proper clinical practice (GCP).

ІІ. Determination of terms

2.1. In this Procedure terms are used in such value:

multicenter clinical testing (research) - testing of medicine according to the single protocol of clinical testing which is carried out more than in one venue of research;

protein is any polymer of alpha amino acid with the specific certain sequence which extent exceeds 40 amino acids. When two or more amino-acid chains in amino-acid polymer are connected with each other naturally, the size of polymer of amino acid will be based on total quantity of amino acids in these chains and will not be limited to amount of amino acids in the continuous sequence;

bioavailability - the speed and degree with which active ingredient or its active component is absorbed (is soaked up) from dosage form and becomes available in the scene of action;

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 degree that effects of these medicines concerning efficiency and safety will be in essence identical;

biological medicinal means - the medicine containing AFI of biological origin (the substance or substances made by biological source or from biological source for assessment and which determination of quality (which) carrying out fiziko-chemical and biological testing in combination with technological assessment of production process and its control is necessary).

Medicines of the advanced therapy, immunological medicines and medicines which receive from blood or plasma of blood of the person, and also the medicines made by means of one of such bioengineering procedures belong to biological medicines:

technology of recombinant DNA;

controlled expression of the genes coding biologically active proteins at прокариот and eukaryote including the transformed cages of mammals;

methods of hybridoma and monoclonal antibodies;

close relatives - and legal value in cases, stipulated by the legislation has physical persons between which natural communication is based on origin one from another or from general ancestors. Close relatives are the husband/wife, parents, children, relatives brothers and sisters;

the brochure of the researcher - abstract statement of preclinical and clinical data on the researched medicine which matter for its studying on the person;

producer of medicine - the legal entity who performs at least one of medicine production phases, including packagings;

homologous use (the same main function / functions) - use of the concept according to which the main functions of cages or tissues of the patient are identical or very similar to their functions at the donor;

researched (the subject of research) - the patient (the healthy volunteer) who according to the operating procedure takes part in clinical testing;

the researched medicine - dosage form of active substance or placebo which is studied or used for comparison in clinical testing, including medicines on which the registration certificate is already issued, but they are used or produced (are constituted or packed) in a different way in comparison with the registered dosage form, or are used on the unregistered displays, or used for more information on the registered medicine form;

the researcher / соисследователь - the doctor who has sufficient professional training and experience of treatment of patients, knows rules of proper clinical practice and the corresponding regulatory legal acts. The researcher bears responsibility for carrying out in the place of research of clinical testing of medicine. If clinical testing is carried out by group of persons in certain venue of research, one of researchers is determined by the responsible head of research group and can be called the responsible researcher;

the file of the researched medicine - information concerning quality of each researched medicine, including medicines of comparison and placebo, and also supplied preclinical researches and the information on the previous clinical testing or clinical use of the researched medicine;

examination of materials of clinical testing - preliminary and specialized examinations of documents (materials) of clinical testing of medicine for the purpose of preparation of conclusions about carrying out clinical testing / rather essential amendment;

health care institution (treatment-and-prophylactic institution) (further - LPZ) the legal entity of any pattern of ownership and form of business or its separate division which main objectives is ensuring medical attendance of the population on the basis of the corresponding license and professional activity of health (pharmaceutical) workers;

legal representatives are parents, adoptive parents, parents tutors, guardians, custodians, representatives of institutions who fulfill duties of guardians and custodians;

the applicant of clinical testing - the physical person or legal entity (for example the sponsor, the contractual research organization) submitting the application for carrying out clinical testing of medicinal means / approval of the commission on questions of ethics concerning carrying out clinical testing / the essential amendment to the central executive body creating and providing realization of state policy in the field of health care (further - TsOIV), and other materials of clinical testing - in the center. The applicant, if he is not sponsor, can submit the corresponding applications only in the presence of the order issued by the sponsor with accurately certain delegated powers;

the report on clinical testing - the results of clinical testing reported in writing and their analysis;

identification code researched / number - the unique identifier which is appropriated by the researcher to each subject of testing for ensuring its anonymity and is used instead of surname in materials of clinical testing;

individual registration form (further - IRF) - the printing, electronic or optical document intended for entering into it of all information provided by the protocol of clinical testing which is subject to transfer to the sponsor, concerning each researched;

the informed consent - the decision to take part in clinical testing which shall be documented in paper or electronic form, is dated and is signed with own hand or the digital signature, is accepted voluntarily, after proper explanation about nature of clinical testing, its value, influence and risk, is appropriately documentary drawn up by person who is capable to agree, or his legal representative (close relative); in exceptional cases, if the corresponding person is incapable to write, it can give oral assent in the presence of, at least, one witness certifying the consent of the subject of research in the written informed consent in paper or electronic form;

clinical testing (research) of medicine - research work which purpose is any research with the assistance of the person as the subject of research, intended for identification or confirmation clinical, pharmacokinetic, phracodynamic and/or other effects, including for studying of absorption, distribution, metabolism and removal of one or several medicines and/or identification of collateral reactions to one or several researched medicines for the purpose of assessment of its safety and/or efficiency;

clinical audit of clinical testing - the procedure of official check of materials (documents) of clinical testing by the Center, rooms, the equipment and equipping, records, systems of security guarantee, quality and other resources which are related to clinical testing and which can contain in treatment-and-prophylactic institution, laboratories, rooms of the sponsor or the contractual and research organization, etc.;

the commission on questions of ethics in case of treatment-and-prophylactic institution (further - the commission on questions of ethics) - independent body which is effective in case of health care institution (treatment-and-prophylactic institution) where clinical testing which includes medical/scientific specialists, persons of other specialties, the public representatives who exercise supervision of observance of the rights, safety, wellbeing of the researched patients (healthy volunteers), ethical and moral legal principles of performing clinical trial are carried out.

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