An integral part of drug development is clinical trials (CT) conducted with the participation of a person as a subject to identify or confirm clinical and/or pharmacological effects of the studied products and/or the identification of undesirable reactions to the studied products, and/or the study of their absorption, distribution, metabolism and excretion in order to evaluate their safety and/or efficiency.
Permission is issued by the Ministry of Health of the Russian Federation on the results of examination of the following documents:
1. Statement
2. Documents confirming payment of state duties
3. Protocol of the clinical trials for the drugs
Protocol is a document that describes the objectives, design, methodology, statistical aspects and organization of the study
4. Investigator’s brochure
Investigator’s brochure is a summary of the results of clinical and preclinical study of the studied product, significant for its research on human beings
5. Patient Information Sheet
Patient Information Sheet is a document containing in an accessible form information concerning the CT of the drug and voluntary consent of the patient to participate in CT of the drug after familiarize themselves with the characteristics of CT relevant to the expression of such consent;
6. Information on the experience of investigators in relevant specialties and their experience in conducting clinical trials
7. Information on medical organizations in which CT of the drug is to be carried out
8. Information on the expected terms of CT of the drug
9. Copies of the contract of compulsory insurance
10. Information about the composition of the drug
11. Document containing indicators (characteristics) of the drug produced for CT
12. Copies of the production license (for manufacturers of the Russian Federation) / copies of the GMP certificate issued in the country of origin (for foreign manufacturers)
Cost and terms:
Within 5 working days, the Ministry of Health prepares and sends to the expert institution and the ethics council the task for carrying out the relevant examinations. Within 30 working daysthe examination of documents and ethical examination is carried out. According to its results, within 5 working days the applicant receives a decision on the issue / refusal to issue a permit for conducting the CI.
1. Duty for carrying out ethical examination, examination of documents for obtaining permission for conducting CT of the pharmaceutical for medical use is 110 000 rubles;
2. Fee for examination of the documents for obtaining permission for international multicenter CT of the pharmaceutical for medical use is 210 000 rubles;
3. The fee for issuing a permission to conduct a clinical trial of a pharmaceutical for medical use is 5 000 rubles;
4. The fee for issuing a permission to conduct an international multicenter clinical trial of a drug for medical use is 5 000 rubles;
References:
1. FZ #61 (Федеральный закон “Об обращении лекарственных средств” от 12.04.2010 N 61-ФЗ)
2. GOST R 52379-2005 (ГОСТ Р 52379-2005 Надлежащая клиническая практика)
3. Order of Minzdrav RF #20n (Приказ Минздрава России от 19.01.2018 N 20н “Об утверждении Административного регламента Министерства здравоохранения Российской Федерации по предоставлению государственной услуги по выдаче разрешения на проведение клинического исследования лекарственного препарата для медицинского применения”)
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©Beawire – April 2019.
