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Association of Clinical Trials Organizations (ACTO)
non-commercial organization of the companies/ legal entities and clinical research community engaged in clinical trials in Russia.

August 31th, 2010

The Government of the Russian Federation adopted the regulation on division of powers between the Ministry of Health and Social Development and Roszdravnadzor

The regulation of the Government of the Russian Federation dated August 20, 2010 650 On Entering Amendments to Certain Legal Acts of the Government of the Russian Federation because of Adoption of the Federal Law On Circulation of Medicines entered amendments to the statutes on the Ministry of Health and Social Development and Roszdravnadzor.

As for clinical trials the Ministry of Health and Social Development adopts legal acts on:

1. ethical council composition, regulations on the council, requirements to qualification and experience of ethical council experts in expert assessment of scientific, medical and ethical aspects of clinical trials of medicinal products for medical use, procedures for arrangement and performance of ethical expert examination and a form of ethical council conclusion,

2. procedures for publication of information on ethical council composition, plan of operation and current activities on the official web-site of the Ministry of Health and Social Development,

3. procedures for issuance of permits to conduct clinical trial of a medicinal product for medical use,

4. rules of good clinical practice,

5. procedures for conduct of bioequivalence and/or therapeutic equivalence studies for generic medicinal products,

6. procedures for maintenance of the register of issued permits to conduct clinical trials of medicinal products for medical use,

7. procedures for publication of 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 for medical use on the official web-site of the Ministry of Health and Social Development,

8. rules of maintenance of the list of investigators who are conducting or conducted clinical trials of medicinal products for medical use and procedures for its publication on the official web-site of the Ministry of Health and Social Development,

9. a form of notice of completion, suspension or cancellation of the clinical trial of the medicinal product for medical use, procedures for its publication on the official web-site of the Ministry of Health and Social Development,

10. procedures for presentation of clinical trial results of a medicinal product for medical use,

11. procedures for conduct of safety monitoring of medicinal products for medical use, registration of side effects, severe adverse reactions and unforeseen adverse reactions that have occurred when administering medicinal products for medical use,

12.procedure for review of the notice on amending the protocol of the clinical trial of the medicinal product for medical use.

The Ministry of Health and Social Development:

- accepts ethical council composition, issues assignments to conduct ethical expert examination of medicinal products for medical use, issues permits to conduct clinical trials of medicinal products for medical use,

- entitles medical institutions to conduct of clinical trials of medicinal products for medical use,

- maintains the list of permits to conduct clinical trials of medicinal products for medical use,

- maintains the list of investigators who are conducting or conducted clinical trials of medicinal products for medical use,

- issues permits to import into the Russian Federation a specific consignment of unregistered medicines to be used in clinical trials of medicinal products for medical use.

In accordance with the regulation Roszdravnadzor supervises clinical trials of medicinal products for medical use and performs safety monitoring of medicinal products being in circulation in the Russian Federation.




 
   
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