Pharmaceutical regulatory terms used in Russia and EAEU

Adverse reaction (adverse drug reaction)

Unintentional adverse reaction of the body that may be associated with the use of a medicinal product (paragraph 50.1 introduced by the Federal Law of 22.12.2014 N 429-FZ)

Active Pharmaceutical Substance (Active Pharmaceutical Ingredient, API)

Medicinal substance in the form of one or several active substances having pharmacological activity regardless of the nature of origin, which is intended for production, manufacture of medicinal products and determines their efficacy (paragraph 2 in the edition of the Federal Law dated 22.12.2014 N 429-FZ)

Batch of a medicine

Certain quantity of a medicine manufactured in the course of one technological cycle by the manufacturer;

Bioequivalence of medicinal products

Achievement of comparable indicators of absorption rate, extent of arrival to the site of action and excretion rate of one or more active substances having pharmacological activity when using medicinal products for medical use having the same international nonproprietary (or chemical or grouping) name, in equivalent dosages and by the same route of administration (item 12.4 introduced by the Federal Law dated 27.12.2019 N 475-FZ)

Bioequivalence study of a medicinal product

Type of clinical study of a medicinal product, which is carried out to determine the rate of absorption and excretion of one or more active substances with pharmacological activity, the amount of the medicinal product reaching the systemic bloodstream, and the results of which make it possible to conclude on the bioequivalence of a reproduced medicinal product in a certain dosage form and dosage, corresponding to the form and doses (paragraph 45 in the edition of the Federal Law dated 22.12.2014 N 429-FZ)

Biological medicinal products

Medicinal products, the active substance of which is produced or isolated from a biological source and for determination of properties and quality of which a combination of biological and physicochemical methods is required. Biological medicinal products include immunobiological medicinal products, medicinal products derived from blood, blood plasma of humans and animals (except for whole blood), biotechnological medicinal products, genotherapeutic medicinal products;

Biosimilar medicinal product (biosimilar)

Biological medicinal product similar in quality, efficacy and safety parameters to the reference biological medicinal product in the same dosage form and having an identical route of administration (item 12.2 introduced by the Federal Law dated 22.12.2014 N 429-FZ)

Biotechnological medicinal products

Medicinal products, the production of which is carried out using biotechnological processes and methods (including DNA recombinant technology, technology of controlled expression of genes encoding biologically active proteins in prokaryotes and eukaryotes, including modified mammalian cells), hybridomics and monoclonal antibody methods (item 7.1 introduced by the Federal Law dated 22.12.2014 N 429-FZ)

Circulation of medicines

Development, preclinical testing, clinical trials, expert examination, state registration, standardization and quality control, manufacturing, compounding, storage, transportation, import into the Russian Federation, export from the Russian Federation, advertising, dispensation, distribution, transfer, use and destruction of medicines;

Common technical document

Set of documents and materials consisting of several sections: administrative documentation, chemical, pharmaceutical and biological documentation, pharmacological, toxicological documentation, clinical documentation and submitted simultaneously with the application for state registration of a medicinal product for medical use in the format established by the authorized federal executive body (p. 21.1 introduced by the Federal Law of 22.12.2014 N 429-FZ)

Comprehensive evaluation of a medicinal product

Evaluation of a registered medicinal product including analysis of information on comparative clinical efficacy and safety of the medicinal product, evaluation of economic consequences of its use, study of additional consequences of the use of the medicinal product in order to make decisions on the possibility of inclusion of the medicinal product in the list of vital and essential medicinal products, normative legal acts and other documents determining the procedure for the provision of medical care, or its exclusion from the said list, acts and documents (paragraph 55 introduced by the Federal Law of 22.12.2014 N 429-FZ)

Counterfeited medicine

Medicine supplied with false information on the composition and/or manufacturer;

Developer of a medicinal product

Organization that has rights to the results of preclinical studies of a medicinal product, clinical studies of a medicinal product and (or) to the technology of production of a medicinal product (ed. Federal Law of 22.12.2014 N 429-FZ)

Dosage form

Condition of a medicinal product corresponding to the modes of administration and use thereof, and ensuring the required therapeutic effect;

Dosage

Content of one or more active substances in quantitative terms per unit dose or unit volume or unit mass according to dosage form or for some types of dosage forms the amount of active substance released from the dosage form per unit time (paragraph 5.1 introduced by the Federal Law dated 22.12.2014 N 429-FZ)