Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 5 Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use - Article 11. Preclinical Testing of a Medicine for Medical Use
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Главная Documents Medical product approval Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 5 Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use - Article 11. Preclinical Testing of a Medicine for Medical Use
Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 5 Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use - Article 11. Preclinical Testing of a Medicine for Medical Use
Article Index
Russian Federation Law №61-FZ March 24, 2010 On Circulation of Medicines. Chapter 5 Development, Preclinical testing of Medicines and Clinical Trials of Medicinal Products for Veterinary Use
Article 10. Development of Medicines
Article 11. Preclinical Testing of a Medicine for Medical Use
Article 12. Preclinical Testing of a Medicine and Clinical Trial of Medicinal Product for Veterinary Use
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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.

 



 
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