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.
The problem is that the report on international projects that meets the requirements of ICH E3, is impossible to prepare in three months, and it cannot be based on conclusions of medical organizations. In such a situation, the best solution would be to amend the existing legislation.
In March 2019, ACTO (Association of Clinical Trials Organizations) sent a letter to the Ministry of Health of the Russian Federation and Roszdravnadzor (Federal Service for Surveillance in Healthcare), where it was noted that the requirements placed on the industry are impossible to fulfill, and as long as the Ministry of Healthcare and Roszdravnadzor come to an agreement and amend the legislation, such violation is unavoidably widespread. The PharmVestnik gazette has published
In April 2019, Roszdravnadzor responded that, considering the importance of arguments set out in ACTO's appeal, the position of Roszdravnadzor on this matter has been submitted to the Ministry of Healthcare of Russia in order to prepare the concerted view.
ACTO's letter has been answered by the Ministry of Health as well. The answer implies, that at present the Ministry is working on harmonization of national legislation containing requirements regarding reports on the results of trials within three months with EAEU legislation, where no deadline is set for the submission of reports on trial results. The Ministry of Health indicated that ACTO proposals will be taken into account wherever possible.