What is the meaning of special conditions for registration of medical drugs for the treatment and prevention of diseases that pose a danger or in emergency situation?

This refers to the fast track registration and conduct of clinical trials, which is valid until January 1, 2021 and is worked out for medical drugs potentially effective in the fight against COVID-191.

State registration of these medical drugs is carried out by the Ministry of Health of the Russian Federation.

The applicant submits for registration an application; administrative documentation; chemical, pharmaceutical, biological documentation; pharmacological, toxicological documentation; clinical documentation.

The exception is a copy of the manufacturer’s report on compliance with the requirements of good manufacturing practice issued in respect of the manufacturing site of the registered medicinal product, as well as a copy of the decision to conduct an inspection of the manufacturer if the medicinal product is produced outside the Russian Federation.

The documents are submitted in the form of e-document management without additional submission of relevant documents and information on hard copy, including, if necessary, their certification only by applicant.

Registration of a medicinal drug is allowed if the clinical documentation is not fully submitted, but then preclinical studies must be conducted in sufficient volume, and the medicinal drug is subject to serial selective quality control.

Specific examination of medical drugs quality and the ratio examination of the expected benefit to the possible risk of a medical use of a drug can be established. Including: reducing the amount of such examinations when amending the registration dossier of the registered medicinal drug by changes associated with the replacement, addition, exception of the manufacturing site of the active pharmaceutical substances manufacturer and pharmaceutical form, changes in primary packaging; the replacement of laboratory examinations research (tests) carried out in relation to a medical drug for the purposes of entry into civil circulation in accordance with art. 521 of the Federal Law dd. 12.04.2010 No. 61-FZ «On drugs circulation».

State registration is carried out within a period not exceeding 20 working days from the date of the application and other documents receipt.

For medical drugs already registered in the EU, USA, and Canada, quality and benefit-to-risk assessments may not be performed. Their registration will take up to five business days. However, such medical drugs are subject to serial selective quality control with mandatory post-registration clinical trials.

The Interdepartmental Commission established at the Russian Ministry of Health is another «special condition», which main aim is to decide about the possibility (or impossibility) of temporary treatment of the medical drug series (batch) not registered in Russia and authorized for medical use on the territory of other states by the competent authorities of the relevant states2. Permit on temporary circulation is issued with regard to the series (batch) of medical drug both having or not analogues of registered in Russia the same active substance and medicinal form, which projected volumes of consumption in an emergency situation exceed the projected volumes of their import or production in Russia.

According to the State Register of Medical Drugs, the Russian Ministry of Health has already issued four decisions on the circulation of medical drugs tocilizumab, baricitinib and hydroxychloroquine during a pandemic3.

1The Resolution of the Government of the Russian Federation dated 03.04.2020 No. 441
2The Order of the Russian Ministry of Health dd. 21.04.2020 No. 358n