Clinical trials

Pursuant to applicable Russian Federation legislation, the release into market circulation of medical products is only permitted upon completion of the mandatory state registration procedure. This procedure is set forth by the provisions of RF Governmental Resolution No. 1416 dated 27 December 2012. Over the course of the procedure, the product is subjected to a number of tests designed to confirm its quality, safe use and efficacy in terms of addressing the medical issue for which it was developed. An important stage of the procedure is the performance of clinical trials.

Clinical trials in the registration procedure

The purpose of performing such trials is to reach a substantiated evaluation of the medical product’s safety and efficacy. The performance of clinical trials is mandatory for all types of medical products. They are also envisioned within the scope of the simplified state-registration procedures introduced by RF Governmental Resolutions No. 430 dated 3 April 2020 and No. 299 dated 18 March 2020 for products that have become high-priority commodities in connection with the spread of the COVID-19 pandemic.

The timing of clinical trials within the overarching structure of registration procedures depends on the class of the potential patient risk associated with the medical product’s use. This class is determined using the methodology set forth in the interstate standard GOST 31508-2012. Thus, for basic products assigned to minimal-risk class 1, clinical trials are conducted at stage I of the state-registration procedure, that is – even before the submission of the respective registration dossier to the oversight agency, in this case: Roszdravnadzor.

Products entailing a higher level of potential usage risk according to GOST 31508-2012, that is – products assigned to classes 2a, 2b and 3, must first complete the phase I expert evaluation of their quality and safety and obtain Roszdravnadzor’s authorization for the performance of clinical trials. Thereafter, the performance of such trials is scheduled.

Types of clinical trials

The rules governing the performance of clinical trials are established in a separate regulation – RF Ministry of Health Order No. 2n dated 09.01.2014. This order sets forth two main forms of the performance of such trials:

• in the form of an evaluation of available clinical data and an analysis of that information. This is the basic type of clinical trial, which is organized for most types of medical products referred for registration;
• in the form of the performance of human trials; This type of trial is used in special situations, for example, when the type of product is fundamentally new to the Russian market or entails the use of unique, complex or special methods for the prevention, diagnosis or treatment of various pathologies. This type of procedure is also selected in the event that the available clinical data on the product fail to prove or insufficiently prove its safety and efficacy for the patient.

Organizations conducting clinical trials

Organizations conducting clinical trials on medical products must satisfy the special requirements set forth in RF Ministry of Health Order No. 300n dated 16 May 2013. The list of these requirements includes:

• the existence of a license to engage in medical activity corresponding to the scope of use of the product being tested;
• the existence in the organization’s articles of incorporation of information to the effect that the performance of clinical trials is one of its core business areas;
• the existence at the organization’s disposal of a separate ward for the provision of intensive care and resuscitation. This requirement applies to companies performing human trials on medical products in classes 2b and 3 – in the event that the trial subject’s condition rapidly deteriorates as a result of the experiment.

Verification of compliance with these requirements is conducted by the respective bodies of Roszdravnadzor. Companies successfully completing this verification are added to the list of accredited medical organizations cleared for the performance of clinical trials. At the Center for the Registration of Medical Products, you can order the turnkey organization of clinical-trial procedures. We’ll handle the compilation of the set of required documents, the performance of the respective trials at accredited medical organizations, and the formalization of the procedure’s results per the established form. We work with all types of products within the scope of both standard and simplified state-registration procedures. The cost of clinical trials for medical products is determined on an individual basis.