Practical Problems & Solutions
ACTO’s Position: Organization and Conduct of CT under the Conditions of a Pandemic
ORGANIZATION AND CONDUCT OF CLINICAL TRIALS UNDER THE CONDITIONS OF A PANDEMIC
31 March 2020
Today, as the new coronavirus infection continues to spread worldwide, regulatory authorities in many countries, including the Russian Federation, have issued recommendations for conducting clinical trials under the pandemic conditions.
On issues concerning carrying out CT of medicinal products in the midst of COVID-19 pandemic
ON ISSUES CONCERNING CARRYING OUT CLINICAL TRIALS OF MEDICINAL PRODUCTS IN THE MIDST OF CORONAVIRUS COVID-19 PANDEMIC
In connection with the World Health Organization declaring the outbreak of a new type of coronavirus COVID-19 a pandemic, the introduction of high-alert status in the Russian Federation and taking into account the current situation in the constituent entities of the Russian Federation, the Ministry of Health of the Russian Federation takes all possible measures aimed to contain the spread of coronavirus infection, also aimed at reduction of social contacts frequency that can contribute to the virus spread.
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. 200í) for trials, for which the applications were filed on 4 September 2016 and later, were approved.