Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Labelling Requirements for Clinical Trials in the EU - Overview of current and future requirements when Regulation (EU) 536/2014 applies ***

Sylvia Hinderfeld (Abschlußjahr: 2018)

Summary
Language: English
The labelling of medicinal products for clinical trials shall ensure subject safety and reliability and robustness of the data generated (First Recital of the Clinical Trials Regulation (EU) No 536/2014). The label allows the identification of the products and the trial and facilitates the proper use and traceability of the products (Article 15 of Directive 2003/94/EC). The label content forms therefore an important part of the clinical trial application and is reviewed and approved by the competent authorities and the ethics committees as part of the submission dossier.
This thesis analysed in chapter 2 the labelling requirements for clinical trials in the EU, based on current applicable regulations as set out in Directive 2001/20/EC, Directive 2003/94/EC, and Annex 13, and how these were transposed into national law by analysing the Regulatory Intelligence information on labelling for the EU Member States. Using Germany as an example, differences between national and EU law are discussed in detail, comparing labelling particulars of Annex 13 Articles 26 to 33 with Article 5 of the German GCP Ordinance.
This thesis also analysed in chapter 3 the labelling requirements of the new Clinical Trials Regulation (EU) No 536/2014, which will apply 6 months after the publication of the functionality of the EU portal, repealing Directive 2001/20/EC. The labelling particulars stipulated in Annex VI of the Clinical Trials Regulation are compared in detail with the particulars listed in Articles 26 to 33 of Annex 13.
The label process, summarised in chapter 2.6, demonstrates the complexity and describes the tasks and stakeholders involved in the preparation of the label text and design for a clinical trial. This process needs to be well managed to ensure regulatory compliance and availability of printed labels and ultimately labelled clinical trial supplies in time. Chapter 4 provides additional recommendations and templates to facilitate this process.
In conclusion, the application of Regulation (EU) No 536/2014 will improve the harmonisation of label requirements within the EU. However, it remains to be seen how the Regulation is interpreted once it applies, especially in the context of the country-specific label content and the requirement for submission of label text translations and label designs.
Pages: 59, Annexes: pages: 9