State registration is one of the key stages in bringing medicinal products, medical devices, and biologically active food supplements to market. The process requires not only the preparation of registration documentation but also a well-developed regulatory strategy that takes into account the applicable legislation and regulatory requirements of the Russian Federation and the Eurasian Economic Union (EAEU).

The registration pathway depends on the product category. For medicinal products, the primary focus is on quality, safety, and efficacy. For medical devices, the assessment covers their safety, performance, and compliance with applicable requirements. Biologically active food supplements (BAAs) are classified as specialized food products and are subject to a separate state registration procedure.

Registration of Medicinal Products
The registration of a medicinal product involves a comprehensive assessment of data relating to its quality, safety, and efficacy.
The main stages include:

• Development of a regulatory strategy;
• Preparation of the registration dossier in the Common Technical Document (CTD) format;
• Compilation and analysis of preclinical and clinical data;
• Preparation of summaries, overviews, and expert documentation;
• Development of the Summary of Product Characteristics (SmPC) and the package leaflet (Patient Information Leaflet);
• User testing of the package leaflet;
• Submission of the registration dossier and support throughout the assessment process;
• Liaison with regulatory authorities;
• Obtaining the Marketing Authorisation (MA).

The quality of the supporting evidence is particularly important. Preclinical and clinical study results must be presented in the registration dossier in a consistent and scientifically justified manner, taking into account the applicable requirements for study conduct and regulatory documentation.

Registration of Medical Devices
The state registration of medical devices follows separate regulatory procedures and differs significantly from the registration of medicinal products.
Depending on the characteristics and intended purpose of a medical device, technical testing, toxicological studies, and clinical investigations may be required.
Regulatory support for medical device registration includes:

• Development of a regulatory strategy;
• Preparation of technical documentation and instructions for use;
• Organization of technical and toxicological testing;
• Preparation of documentation relating to completed clinical investigations;
• Organization and support of clinical investigations;
• Preparation of clinical evaluation reports and summaries;
• Support throughout the regulatory assessment process;
• Obtaining the medical device registration certificate.

A new procedure for the state registration of medical devices has been in force in the Russian Federation since 1 March 2025. Therefore, when planning a registration project, it is essential to take into account the current regulatory requirements and the applicable requirements for supporting evidence.

Registration of Biologically Active Food Supplements
Biologically active food supplements (BAAs) are classified as specialized food products rather than medicinal products. Their market placement requires completion of the established state registration procedure.
Before initiating registration, it is important to assess the product composition, raw materials used, ingredient dosages, safety, labelling, and intended claims.
Regulatory support for the registration of dietary supplements may include:

• Analysis of the product composition and assessment of its registration eligibility;
• Preparation of registration documentation;
• Preparation and submission of the application;
• Coordination and support of laboratory testing;
• Organization of clinical studies, where necessary;
• Liaison with expert organizations and regulatory authorities;
• Support throughout the procedure until the State Registration Certificate (SRC) is obtained.

Dietary supplements must not be marketed as medicinal products or attributed therapeutic properties. The need for additional studies is determined based on the characteristics of the specific product and its development objectives.

Why Is It Important to Develop a Regulatory Strategy at an Early Stage?
One of the common mistakes when bringing products to market is conducting studies without taking into account the future requirements for the registration dossier.
A regulatory strategy should be developed at the product development stage. This makes it possible to identify the necessary studies, documentation requirements, and supporting evidence in advance, while reducing the risk of additional costs and registration delays.
It is particularly important to ensure consistency between study results, technical documentation, and registration materials.

State Registration in Russia and the EAEU
To enter the market, it is necessary to determine the applicable registration pathway based on the product category and the regulatory requirements of the relevant country.
Different regulatory frameworks apply to medicinal products, medical devices, and specialized food products. Therefore, there is no universal registration pathway suitable for all product categories.
A well-developed regulatory strategy helps establish the sequence of actions, identify the necessary studies, and determine the composition of the registration dossier in advance.

Comprehensive Regulatory Support
We provide support throughout the key stages of the state registration process, from developing a regulatory strategy and preparing documentation to liaising with expert organizations and regulatory authorities and obtaining the relevant registration document.
Depending on the project, our specialists can undertake:

• Development of a regulatory strategy;
• Preparation of the registration dossier;
• Organization of preclinical, clinical, technical, and toxicological studies;
• Preparation of clinical and expert documentation;
• Support throughout the regulatory assessment process;
• Preparation of responses to regulatory authority requests;
• Assistance in obtaining a Marketing Authorisation or State Registration Certificate.

State registration involves much more than document preparation. It is a comprehensive process in which scientific evidence and regulatory strategy must be developed as an integrated system.