Article 38. Clinical Trials of Medicinal Products for Medical Use

1. Clinical trials of medicinal products for medical use, including international multicentre, multicentre, post-registration trial shall be conducted for the purpose of state registration of medicinal products and for any other purposes on one or more medical institutions as required by goods clinical practice approved by the authorized federal executive body for the following purposes:

1) to establish safety and/or tolerance of medicinal products for healthy volunteers, except for the trials of medicinal products manufactured outside the Russian Federation;
2) to select optimal dosages of medicinal product and course of treatment for patients with specific disease, optimal dosages and vaccination schemes of immunobiological medicinal products for healthy volunteers;
3) to establish safety and efficacy of a medicinal product for patients with specific disease, prophylactic efficacy for immunobiological medicinal products for healthy volunteers;
4) to study the possibility to widen the indication for medical use and identify earlier unknown side effects of registered medicinal products.

2. Generic medicinal products intended for medical use are subject to trials for bioequivalence and/or therapeutic equivalence in the procedure established by the authorized federal executive body.

3. Clinical trials of a medicinal product for medical use may be organized by:

1) developer of the medicinal product or by a person authorized by the developer;
2) educational institutions of higher and/or additional professional education;
3) research centres.

4. Clinical trials of medicinal products for medical use shall be conducted in the procedure prescribed by Articles 20 - 22 of this Federal Law under the permit to conduct the clinical trial of the medicinal product issued by the authorized federal executive body for the purposes specified in
Clause 1 of this Article. The authorized federal executive body shall maintain a register of issued permits to conduct clinical trials of medicinal products indicating the purpose or purposes thereof in the procedure established by such body.

5. In the event of state registration of a medicinal product, the state duty for expert examination of the documents required for obtaining permits to conduct clinical trials of a medicinal product for medical use and ethical expert examination, when an application is filed for state registration of the medicinal product for the purpose or purposes referred to in Clause 1 of this Article, shall be paid once.

6. The developer of a medicinal product may involve legal entities of any form of incorporation to organization of clinical trials of a medicinal product for medical use provided that these trials comply with the requirements of this Federal Law.

7. Clinical trials of medicinal products for medical use shall be carried out in medical institutions accredited by the authorized federal executive body in the manner prescribed by the Government of the Russian Federation.

8. The list of medical institutions entitled to conduct clinical trials of medicinal products for medical use and the register of issued permits to conduct clinical trials of medicinal products shall duly be published and placed on the official web-site by the authorized federal executive body.