Някои актуални проблеми в правната уредба на клиничните изпитвания на лекарствени продукти
Some current issues in the legal framework on clinical trials of medicinal products
Author(s): Veska GergovaSubject(s): Law, Constitution, Jurisprudence, EU-Legislation, Administrative Law
Published by: Съюз на юристите в България
Keywords: clinical trial; medicinal product; authorization; optimization
Summary/Abstract: The article analyzes the legal framework on clinical trials of medicinal products under Regulation (EU) No 536/2014 of the European parliament and of the Council, in particular the authorization procedures for a clinical trial and substantial modification of a clinical trial. Both the achievements of the legislation and some gaps are discussed. They are commented in relation to the national legislation under the Medicinal Products in Human Medicine Act. Some recommendations and de lege ferenda proposals are made.
Journal: Общество и право
- Issue Year: 2022
- Issue No: 5
- Page Range: 73-91
- Page Count: 19
- Language: Bulgarian
- Content File-PDF