Russian Pharmaceutical Regulation

Federal Law on Medicines Circulation

The Federal Law on the Circulation of Medicines (Federalny Zakon ob Obrashchenii Lekarstvennykh Sredstv, No. 61-FZ of 12 April 2010) is the principal regulatory statute governing pharmaceutical products in the Russian Federation. The Law, extensively amended since adoption, covers the entire lifecycle of medicines: development, preclinical and clinical trials, state registration (gosudarstvennaya registratsiya), production, quality control, distribution, dispensing, and pharmacovigilance. The Law applies to both human and veterinary medicines and distinguishes between original medicines (originalnye preparaty) and reproduced medicines (vosproizvedyonnye preparaty, generics).

The Ministry of Health of the Russian Federation (Minzdrav) is the primary regulatory authority for medicines, exercising functions including: registration of medicines; authorisation of clinical trials; inspection of manufacturing facilities for GMP compliance; maintenance of the State Register of Medicines (Gosudarstvenny Reestr Lekarstvennykh Sredstv); and establishment of the List of Vital and Essential Medicines (Perechen Zhiznenno Neobkhodimykh i Vazhneyshikh Lekarstvennykh Preparatov, ZHNVLSP). The Federal Service for Surveillance in Healthcare (Roszdravnadzor) monitors compliance with pharmaceutical regulation during production, storage, distribution, and dispensing.

Drug Registration Procedure

State registration is mandatory for all medicines intended for circulation on the Russian market, governed by Articles 26–36 of 61-FZ and Decree No. 438 of 2010 on the Registration Procedure. The registration process involves: (1) submission of a registration dossier to the Ministry of Health, containing administrative documents, quality data (pharmaceutical), preclinical data (pharmacological and toxicological), and clinical trial data; (2) expert review conducted by the Federal State Budgetary Institution Scientific Centre for Expert Evaluation of Medicinal Products (FGBU NCESMP) under the Ministry of Health; (3) quality testing of three production batches by an accredited testing laboratory; (4) ethics review by the Ministry of Health Ethics Council; and (5) decision by the Ministry of Health on registration.

The registration period is approximately 210 working days for original medicines and 160 working days for generics. Registration is valid for five years, after which renewal (podtverzhdenie registratsii) is required. The EAEU harmonised registration procedure (effective from 2021) provides an alternative pathway: medicines registered under EAEU rules by the EAEU reference authority (the Ministry of Health of one member state) benefit from mutual recognition in all EAEU member states without separate national registration.

GMP Certification

Good Manufacturing Practice (GMP) certification is mandatory for all pharmaceutical manufacturers supplying the Russian market. The GMP Rules of the Eurasian Economic Union (TR EAEU 006/2019), adopted by EEC Decision No. 73 of 2018, establish uniform manufacturing quality standards across the Union. The Rules are based on the WHO GMP guidelines and ICH Q7 and incorporate specific requirements for: (1) premises and equipment; (2) personnel and training; (3) documentation and batch records; (4) quality control and quality assurance; (5) validation of manufacturing processes; (6) stability testing; and (7) complaint handling and recall procedures.

The Ministry of Industry and Trade (Minpromtorg) conducts GMP inspections of manufacturing facilities, both domestic and foreign, through its Department of GMP Inspection. Foreign manufacturers must undergo an on-site inspection by Russian or EAEU inspectors every three years. The GMP certificate issued following a successful inspection is valid for three years. As of 2026, approximately 60% of foreign pharmaceutical manufacturers serving the Russian market have completed GMP certification, with the remainder relying on transitional arrangements that are being phased out.

Clinical Trials Regulation

Clinical trials in Russia are regulated by Articles 36.1–46 of 61-FZ and Order No. 200n of 2012 of the Ministry of Health. The types of trials include: (1) bioequivalence studies (issledovaniya bioekvivalentnosti) for generic medicines; (2) Phase I–III therapeutic confirmatory trials for original medicines; (3) post-marketing Phase IV studies; and (4) localised trials required for registration of foreign medicines where the initial clinical data were obtained outside Russia. The Ministry of Health must authorise each trial within 60 days of application. The Ethics Council under the Ministry of Health provides mandatory ethics review.

Trial sponsors may be Russian or foreign legal entities. Foreign sponsors must appoint a Russian representative to assume legal responsibility for trial conduct. The Insurance of Clinical Trial Subjects is mandatory under Article 44 of 61-FZ, requiring coverage of 2 million RUB per subject for life and health risks. The Federal Service for Surveillance in Healthcare (Roszdravnadzor) conducts inspections of clinical trial sites, contract research organisations (CROs), and ethics committees.

Pricing Regulation and the ZHNVLSP List

Medicines included in the List of Vital and Essential Medicines (ZHNVLSP) are subject to state price regulation. The list, updated annually by the Government under Article 60 of 61-FZ, currently includes over 800 international nonproprietary names (INNs) covering most therapeutic categories. The Methodology for Price Setting (Decree No. 1313 of 2022) establishes a reference pricing system: the manufacturer’s actual selling price (fabrichno-otpusknaya tsena) is registered by the Ministry of Health and may not exceed the maximum registered price. Wholesale and retail markups are regulated by regional authorities within federal parameters.

For non-listed medicines, pricing is generally free, though the Federal Antimonopoly Service (FAS) may intervene where prices are found to be monopolistically high or where there is evidence of anticompetitive agreements among manufacturers or distributors. The FAS has pursued enforcement actions against pharmaceutical companies for abuse of dominance in the market for specific active pharmaceutical ingredients (APIs).

Mandatory Labelling System (Chestny Znak)

The mandatory digital labelling system known as Chestny Znak (Chestny Znak, meaning “Honest Mark”) was introduced for medicines through Decree No. 1556 of 2019 and became mandatory from 1 July 2020. The system requires that each primary packaging unit of a medicine bear a unique Data Matrix code that can be scanned at each point in the supply chain — from manufacturer to wholesaler to pharmacy or hospital. The code contains information on product identification, batch number, expiration date, and serial number.

The system is administered by the Operator of the National Digital Marking and Traceability System (Operator-CRPT). Pharmaceutical manufacturers, importers, wholesalers, and retailers must register with the system, submit serialisation data, and scan codes upon receipt, sale, or disposal of medicines. The system has been credited with reducing the circulation of counterfeit medicines, which was estimated at approximately 5% of the market before its introduction. Fines under Article 15.12 of the Code of Administrative Offences for non-compliance with labelling requirements range from 50,000 to 300,000 RUB for officials and legal entities, with confiscation of unlabelled products.

Pharmacovigilance

The pharmacovigilance (farmakonadzor) system under Articles 64–69 of 61-FZ requires that marketing authorisation holders monitor the safety of their medicines and submit periodic safety update reports (PSURs) to Roszdravnadzor. The Automated Information System of Roszdravnadzor (AIS Roszdravnadzor) collects and processes adverse drug reaction reports from healthcare professionals, patients, and pharmaceutical companies. The obligation to report serious adverse reactions within 15 days (or 7 days for fatal reactions) applies to both authorised medicines and medicines undergoing clinical trials.