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.

In recent years, the drug registration system in Russia has undergone significant changes due to the harmonization of legislation with the requirements of the Eurasian Economic Union (EAEU). Manufacturers and marketing authorization holders must take into account both the provisions of Federal Law No. 61-FZ “On the Circulation of Medicines” and the regulatory documents of the EAEU.

What Is State Registration of a Medicinal Product?
State registration of a medicinal product is a set of expert and administrative procedures aimed at confirming that the product complies with established quality, safety, and efficacy requirements.
After successful completion of the registration procedure, the applicant receives a marketing authorization, and information about the medicinal product is entered into the State Register of Medicines (GRLS). The medicinal product may then be placed into civil circulation.
The main objectives of registration are:

• confirmation of a positive benefit-risk balance;
• control of manufacturing quality;
• protection of patients from the circulation of poor-quality, unsafe, or ineffective medicinal products;
• ensuring uniform requirements for the circulation of medicinal products.

Regulatory Framework
The registration procedure is regulated by several levels of legislation.
The main regulatory documents include:

• Federal Law No. 61-FZ “On the Circulation of Medicines”;
• the EAEU Rules for the Registration and Examination of Medicinal Products (Decision No. 78 of the Council of the Eurasian Economic Commission);
• Good Manufacturing Practice (GMP) requirements;
• requirements for the Common Technical Document (CTD);
• regulatory documents of the Russian Ministry of Health and the Eurasian Economic Commission.

It should be noted that the transition to unified procedures for the registration of medicinal products within the EAEU is still ongoing. Transitional provisions apply to certain categories of medicinal products. Therefore, applicants should rely on the current requirements of the applicable legislation.
Which Medicinal Products Are Subject to State Registration?
Almost all medicinal products intended for medical use are subject to registration.

These include:

• innovative medicinal products;
• generic medicinal products;
• biological medicinal products;
• biosimilars;
• orphan medicinal products;
• radiopharmaceuticals;
• immunobiological medicinal products;
• herbal medicinal products.

Special requirements regarding the scope of studies and the content of the registration dossier apply to certain categories of products.

Main Stages of Drug Registration
Stage 1. Drug Development
The first stage involves a complete development program, including:

• identification and development of the active substance;
• pharmaceutical development;
• preclinical studies;
• development of the manufacturing process;
• validation of analytical methods.

Preclinical studies make it possible to assess the toxicity, pharmacokinetics, pharmacodynamics, and potential safety of a medicinal product before studies involving humans begin.

Stage 2. Conducting Clinical Trials
Clinical trials are a mandatory stage in confirming the efficacy and safety of a new medicinal product.
Modern clinical trials are conducted in accordance with the principles of Good Clinical Practice (GCP) and include several phases.
During clinical trials, the following aspects are assessed:

• treatment efficacy;
• safety profile;
• frequency of adverse reactions;
• optimal dosing regimen;
• benefit-risk balance.

For generic medicinal products, the scope of clinical studies is usually smaller and may be limited to bioequivalence studies.

Stage 3. Preparation of the Registration Dossier
All materials are compiled into a registration dossier in the international Common Technical Document (CTD) format.
The dossier consists of five modules:

• administrative information and documents;
• overviews of quality, safety, and efficacy;
• information on the quality of the medicinal product;
• non-clinical study reports;
• clinical study reports.

The completeness and quality of the registration dossier have a significant impact on the duration of the state registration procedure.

Stage 4. Submission of the Application
The applicant submits the required set of documents to the authorized government authority.
After a preliminary review of the completeness of the submitted materials, the expert assessment procedure begins.

Stage 5. Assessment of Quality, Efficacy, and Safety
This is the most time-consuming stage of the registration process.
Expert organizations assess:

• compliance of manufacturing with GMP requirements;
• laboratory quality control results;
• preclinical study data;
• clinical study results;
• quality of statistical data analysis;
• reliability of conclusions regarding the efficacy of the medicinal product;
• safety profile.

If necessary, the applicant may receive requests to provide additional materials or clarifications.

Stage 6. Decision-Making
Based on the results of the expert assessment, one of the following decisions is made:

• registration of the medicinal product;
• refusal of registration;
• suspension of the procedure until identified deficiencies are addressed.

Common Misconceptions“Registration Is a Simple Administrative Procedure”
This is incorrect. State registration involves a scientific assessment of the quality, efficacy, and safety of the medicinal product.

“It Is Enough to Confirm Efficacy”
No. The decision is based on a comprehensive assessment of the benefit-risk balance, manufacturing quality, and compliance with all applicable regulatory requirements.

“All Medicinal Products Follow the Same Registration Procedure”
No. Requirements differ for innovative medicinal products, generics, biological medicinal products, biosimilars, orphan medicinal products, and other categories of medicinal products.

Conclusion
Drug registration in Russia is a multi-stage procedure based on the principles of evidence-based medicine and international standards for assessing the quality of medicinal products. Key elements of the process include sound pharmaceutical development, preclinical and clinical studies, preparation of the registration dossier, and successful completion of the state expert assessment.

Given the gradual transition toward unified registration rules within the EAEU, manufacturers should regularly monitor changes in the regulatory framework and take into account the current requirements of regulatory authorities. Proper preparation of documentation, compliance with GMP and GCP requirements, and the use of high-quality evidence can significantly increase the likelihood of successful drug registration and reduce the time required to bring a medicinal product to the market.