Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The New Regulation 536/2014 on Clinical Trials on Medicinal Products for Human Use – Opportunities and Challenges for European Clinical Research ***

Nahid Roushanaei (Abschlußjahr: 2014)

Summary
Language: English
“In a clinical trial the rights, safety, dignity and well-being of subjects should be protected and the data generated should be reliable and robust. The interest of the subjects should always take priority over all other interests”. With this first Recital the Regulation (EC) 536/2014 starts.
Clinical trials conducted in the Member States of the European Union before 2004 were ruled by national law. In the course of further harmonisation within the Union, the Directive 2001/20/EC was released on April 4, 2001 and came into force on May 1, 2004. Since then clinical trials are authorised on the same legal basis in theory. As this was a Directive, only the principles had to be implemented in national legislation and thus, in practice, the same legal basis was not been implemented identically into national legislation. The slight differences in each national legislation caused e.g. administrative burdens for the sponsors when preparing an application dossier for authorising especially a multi-national clinical trial.
This master thesis describes the development of the Clinical Trials Directive 2001/20/EC to the Regulation (EC) 536/2014.
The main focuses are the assessment procedure of the application dossier and the technical requirements according to the Regulation.
The aim of this thesis is to illustrate the importance of regulating clinical trials on the European scale. “Without clinical trials, there would be no new medicines, no further development of existing medicines, and no evidence-based improvement of treatments with medicines”.
Pages: 70, Annexes: 2