Nonclinical studies are conducted to characterize the pharmacological activity, pharmacokinetic properties, and potential safety risks of a medicinal product before its administration to humans. The scope of the nonclinical development program is determined on a case-by-case basis, taking into account the characteristics of the active substance, pharmaceutical dosage form, route of administration, therapeutic indication, and available scientific data.

In many research sites, inspection preparation is still perceived as an emergency process. A few weeks before the inspectors’ visit, staff begin reviewing document folders, searching for missing signatures, and urgently updating logs. In practice, this approach rarely leads to good results. A modern GCP inspection assesses more than just the state of documentation on a particular day. Inspectors want to understand how effectively the site operates as a whole, how decisions are made, how deviations are managed, and how reliable the study data are.

The sponsor of a clinical trial plays a key role in the development of new medicinal products and medical devices. The sponsor initiates the trial, defines its objectives, provides funding, and is responsible for compliance with applicable legislation, international Good Clinical Practice (GCP) standards, and the protection of participants’ rights.

The selection of a research site is one of the key stages in the preparation of a clinical trial. The quality of the selected research site has a significant impact on patient recruitment timelines, the quality of collected data, compliance with Good Clinical Practice (GCP) requirements, participant safety, and the successful completion of the project.

Drug registration is a mandatory stage before a medicinal product can be placed on the Russian market. Only after state registration can a drug be legally manufactured, imported, marketed, and used in medical practice. The main purpose of the procedure is to confirm the quality, efficacy, and safety of the medicinal product based on the results of preclinical and clinical studies.

Contract Research Organizations (CROs) play a critical role in the conduct of modern clinical trials. Pharmaceutical companies, biotechnology firms, medical device manufacturers, and academic institutions engage CROs to perform a wide range of activities related to the organization, coordination, and management of clinical research.

Clinical trial monitoring is one of the key components of the quality assurance system in the development of new medicinal products and medical devices. Its primary purpose is to ensure compliance with the study protocol, Good Clinical Practice (GCP) requirements, and applicable regulations, while protecting the rights, safety, and well-being of study participants.

Bioequivalence studies are a mandatory step in the registration of most generic medicinal products. These studies demonstrate that a generic drug is as effective and safe as the reference (originator) product.

Following the COVID-19 pandemic, remote and hybrid GCP inspections have become a permanent part of international regulatory practice. Today, regulators actively use remote inspection formats to assess clinical trial compliance with regulatory requirements.

The dietary supplement (DS) market in Russia continues to develop rapidly. According to industry research, consumer demand for dietary supplements is increasing every year, while the range of available products is becoming increasingly diverse. At the same time, government authorities are placing greater emphasis on the quality, safety, and scientific substantiation of the claimed properties of dietary supplements.

Dietary supplements have long occupied an important place in preventing nutrient deficiencies and supporting overall health. However, for many years, their effectiveness remained a subject of discussion among physicians, nutrition specialists, and consumers.

The dietary supplement market in Russia is gradually moving toward stricter evidence-based standards. Following the introduction of new requirements for substantiating the effectiveness of dietary supplements, the topic of clinical studies has become especially relevant.

The Russian market for dietary supplements (DS) is transitioning to new regulatory requirements. By Resolution No. 398 of the Government of the Russian Federation dated April 13, 2026, criteria for the quality and efficacy of dietary supplements, as well as requirements for substantiating their claimed properties, have been approved.

The development of a new medicinal product is a complex and costly process in which clinical trials play a critical role in confirming the efficacy and safety of a therapy.

Clinical trials in Russia in 2026 remain one of the most expensive stages in bringing a new pharmaceutical product or medical device to market. At the same time, project costs may vary by dozens of times — from several million rubles for a local bioequivalence study to hundreds of millions or even billions of rubles for international multicenter Phase III programs.

Clinical trials in Russia in 2026 remain one of the most expensive stages in bringing a new pharmaceutical product or medical device to market. At the same time, project costs may vary by dozens of times — from several million rubles for a local bioequiva