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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.

Practical Problems & Solutions

On submission of reports on the results of ICT to the Ministry of Health of the Russian Federation

ON SUBMISSION OF REPORTS ON THE RESULTS OF INTERNATIONAL CLINICAL TRIALS TO THE MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION WITHIN THREE-MONTH PERIOD AFTER COMPLETION OF THE TRIAL

The Russian legislation requires that a report on the results of clinical trials compiled “on the basis of conclusions of the medical organizations involved in this trial” are submitted to the Ministry of Health within a three-month period after completion of trials (Part 11, Article 40 of the Federal Law dated 12 April 2010 No. 61-FZ " On Circulation of Medicines"). Moreover, the substantive requirements to the final report complying with international document ICH E3 (Par. 9 of the Rules of Good Clinical Practices approved by the Order of the Ministry of Health of the Russian Federation dated 04 April 2016 No. 200н) for trials, for which the applications were filed on 4 September 2016 and later, were approved.

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