Theory and practice of intellectual property
№ 2 / 2018

ISSN (Print) 2308-0361
ISSN (Online) 2519-2744

PDF (Ukrainian)

DOI: https://doi.org/10.33731/22018.146330

Published      2018-05-04

Legislative regulation of generics in Ukraine and the USA: comparative and legal analyses

Inna Volynets
Ukraine

Abstract
The study aimed to investigate features of legal regulation of generic medicines. The definition of the term “generic” is provided. The comparative analyses were performed between the original medicinal products and the generics. There were performed analyses for international legislation on registration, certification, compliance with quality and safety standards for the production of generic drugs. There was analyzed the law of the USA “The Federal Food, Drug, and Cosmetic Act (FD&C)”, regulating the quality of production of medicinal products, verification of production before going to market, the prevention of the counterfeits production. The Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards were studied in relation to their implementation by national legislation, and compliance with the provisions in the local pharmaceutical market. EU Directive 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC on which based the “Good Manufacturing Practice” to be characterized in Ukraine. The amendment was evaluated for the “The Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act”, which is maintained a balance between the patent holders of the drug and the production of their generic copies before the expire date of the patent. The study is investigated development and production perspective of generics in the world is conducted.

Keywords: medicines, generic, clinical trials, manufacturing practice, standard, patent, directives