Chapter 5. Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use

Table of contents

Chapter 1. General Provisions (articles 1-4)
Chapter 2. Powers of Federal Executive Bodies and Executive Bodies of Constituent Entities of Russian Federation with Respect to Circulation of Medicines (articles 5-6)
Chapter 3. State Pharmacopeia (article 7)
Chapter 4. State Control over Circulation of Medicines (articles 8-9)
Chapter 5. Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use (articles 10-12)
Chapter 6. Performance of State Registration of Medicinal Products (articles 13-37)
Chapter 7. Clinical Trials of Medicinal Products for Medical use, Clinical Trial Contract, Rights of Patients Involved in Trials (articles 38-44)
Chapter 8. Manufacture and Marking of Medicines (articles 45-46)
Chapter 9. Import of Medicines into the Russian Federation and Export of Medicines from the Russian Federation (articles 47-51)
Chapter 10. Pharmaceutical Activity (articles 52-58)
Chapter 11. Destruction of Medicines (article 59)
Chapter 12. State Regulation of Prices for Medicinal Products for Medical Use (articles 60-63)
Chapter 13. Safety Monitoring of Medicinal Products Being in Circulation in the Russian Federation (articles 64-66)
Chapter 14. Information on Medicinal Products (article 67)
Chapter 15. Liability for Violation of Legislation of the Russian Federation for Medicines Circulation and Compensation for Harm to Human Health Caused by Administration of Med (articles 68-69)
Chapter 16. Final Provisions (articles 70-71)

Article 10. Development of Medicines

1. Development of medicines involves the search for new pharmacologically active substances, subsequent investigation of their medicinal properties, preclinical testing, development of manufacturing technologies for pharmaceutical substances, development of compositions of and manufacturing technologies for medicinal products.

2. Financing of the development of medicines is provided using:

1) federal funds;
2) funds of developers of medicines;
3) funds of manufacturers of medicines within the framework of R&D projects implemented under a contract between the developer of the medicines and the manufacturer of the medicines;
4) other sources not prohibited by the legislation of the Russian Federation.

3. The rights of a developer of a medicine are protected by the civil legislation.

Article 11. Preclinical Testing of a Medicine for Medical Use

1. A preclinical testing of a medicine for medical use is conducted using scientific assessment methods for the purpose of obtaining evidence of safety, proper quality and efficacy of the medicine.

2. A preclinical testing of a medicine for medical use is conducted in compliance with the good laboratory practices approved by the authorized federal executive body.

3. Developers of medicines may involve research institutions and institutions of higher professional education, which have a necessary material and technical base and qualified specialists in the relevant research area, to arrange and conduct a preclinical testing of a medicine for medical use.

4. A preclinical testing of a medicine for medical use shall be conducted in accordance with the plan approved by the developer of the medicine with the trial protocol keeping and generating a report which should contain the trial results and conclusion on the possibility of a clinical trial of the medicinal product for medical use.

5. Inspections for compliance with the good laboratory practices and statutory regulations on the use of animals in preclinical testing of medicines for medical use shall be carried out by the authorized federal executive body.

6. The results of a preclinical testing of a medicine for medical use may be submitted to the authorized federal executive body in accordance with the standard procedure for the purpose of state registration of the medicinal product.

Article 12. Preclinical Testing of a Medicine and Clinical Trial of Medicinal Product for Veterinary Use

1. A preclinical testing of a medicine for veterinary use shall be conducted using scientific assessment methods for the purpose of obtaining evidence of safety, proper quality and efficacy of the medicine, including, but not limited to determination of the period of its excretion from the animal body, in order to ensure safety of animal products after the use of the relevant medicinal product.

2. A preclinical testing of a medicine, a clinical trial of a medicinal product for veterinary use and a bioequivalence study of such medicinal product shall be conducted in compliance with the regulations approved by the authorized federal executive body.

3. A preclinical testing of a medicine and a clinical trial of a medicinal product for veterinary use are conducted in accordance with the plan approved by the developer of the medicine with the trial protocol keeping and generating reports which should contain the trial results.

4. A developer of a medicine may engage institutions which have a necessary material and technical base and qualified specialists in the relevant research area, to arrange and conduct a preclinical testing of a medicine and a clinical trial of a medicinal product for veterinary use.

5. Clinical trials of medicinal products for veterinary use are conducted in veterinary institutions and institutions engaged in animal breeding, farming and keeping, for the purpose of:

1) determination of tolerance for medicinal products with healthy animals;
2) optimization of dosage rates of medicinal products and a course of treatment within a particular group of animals having a certain disease;
3) determination of safety and efficacy of a medicinal product with animals having a certain disease, or prophylactic efficacy of a medicinal product with healthy animals;
4) study of possibilities to extend indications of a registered medicinal product and to reveal previously unknown side effects.

6. A clinical trial of a medicinal product for veterinary use is conducted at the expense of the developer of the medicine.

7. Reports on the results of a preclinical testing of a medicine and clinical trial of a medicinal product for veterinary use are generated by the developer of the medicine in consideration of the conclusions made by the institutions involved in the arrangement and conduct of the trials.

8. Control over the conduct of preclinical testing of medicines and clinical trials of medicinal products for veterinary use shall be carried out by the authorized federal executive body.

Table of contents

Chapter 1. General Provisions (articles 1-4)
Chapter 2. Powers of Federal Executive Bodies and Executive Bodies of Constituent Entities of Russian Federation with Respect to Circulation of Medicines (articles 5-6)
Chapter 3. State Pharmacopeia (article 7)
Chapter 4. State Control over Circulation of Medicines (articles 8-9)
Chapter 5. Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use (articles 10-12)
Chapter 6. Performance of State Registration of Medicinal Products (articles 13-37)
Chapter 7. Clinical Trials of Medicinal Products for Medical use, Clinical Trial Contract, Rights of Patients Involved in Trials (articles 38-44)
Chapter 8. Manufacture and Marking of Medicines (articles 45-46)
Chapter 9. Import of Medicines into the Russian Federation and Export of Medicines from the Russian Federation (articles 47-51)
Chapter 10. Pharmaceutical Activity (articles 52-58)
Chapter 11. Destruction of Medicines (article 59)
Chapter 12. State Regulation of Prices for Medicinal Products for Medical Use (articles 60-63)
Chapter 13. Safety Monitoring of Medicinal Products Being in Circulation in the Russian Federation (articles 64-66)
Chapter 14. Information on Medicinal Products (article 67)
Chapter 15. Liability for Violation of Legislation of the Russian Federation for Medicines Circulation and Compensation for Harm to Human Health Caused by Administration of Med (articles 68-69)
Chapter 16. Final Provisions (articles 70-71)