Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Radiopharmaceuticals - are their peculiarities adequately reflected in European legislation? ***

Dr. Andrea Schüssele (Abschlußjahr: 2012)

Language: English

Radiopharmaceuticals are a heterogeneous class of medicinal products that were originating from nuclear research institutions. It was only in 1992 that they were subjected to the pharmaceutical legislation in the EU by means of Directive 89/343/EEC. At that time, the peculiarities of radiopharmaceuticals made it necessary to adjust some of the principles generally employed medicinal products. Due to their short half-life, some radiopharmaceuticals are marketed in the form of kits that have to be combined with radioisotopes just before the administration to the patient. This so-called “extemporaneous preparation” is exempted from the need for a marketing authorisation according to Art. 7 of Directive 2001/83/EC as long as it is performed in an “authorised establishment”. It was the goal of this thesis to investigate how selected EU member states have transformed Art. 7 into their national law. A brief overview of the systems in Germany, United Kingdom, France and Spain is given. Applicable quality standards for extemporaneous preparation are presented as the EU-GMP-guidelines (Eudralex Volume 4) do not apply. The different concepts were compared to the German system and issues were identified both on national and EU-level where the current regulatory environment is not suited for radiopharmaceuticals or might be a hindrance for their further development. In conclusion, 20 years after radiopharmaceuticals became medicinal products there is still potential for further improvements in the European legislation.

Pages: 53;
Annexes: A, B, C,
pages: 4, 2, 5