Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Labelling requirements for investigational medicinal products in multinational studies: bureaucratic cost driver or added value? ***

Dr. Astrid Weyermann (Abschlußjahr: 2006)

Language: English

The purpose of regulatory labelling requirements for investigational medicinal products (IMPs) in clinical trials (CTs) is to provide added value regarding

• Protection of the subjects
• Identification of the IMP
• Traceability of the IMP
• Proper use of the IMP
• Identification of the trial
• Proper documentation of the trial

The compliance with these requirements is important for drug development as non-compliance may cause problems during the approval process.

The detailed regulatory requirements for the labelling of an IMP are described and the differences are discussed for several countries of the ICH regions. It is concluded that especially the divergent national implementation of the EU-requirements may be regarded as a bureaucratic burden. This may result in increased costs especially in multinational clinical trials without providing additional benefit for subjects and safe conduct of the CT.

The regulatory requirements compiled and summarised by regulatory affairs (RA) provide the basis of the decision process to make the best-balanced choice for the labelling of the IMP. To assume the responsibility for the labelling throughout the life cycle of the medicinal product, RA will organise this decision process, which involves close cross-functional communication of several departments and where RA is the interface to all stakeholders of the workflow.

A proposal for the organisation of the workflow is described. It can be regarded as a pars pro toto example for several other workflows involving multiple departments and organised by RA. Possible alternatives for the labelling decision and also measures to avoid potential problems are discussed in general terms focussing on compliance issues, technical and logistic feasibility as well as adherence to timelines.

The RA manager optimises the labelling of IMPs in multinational CTs to reduce the bureaucratic costs and to maximise the added value of the labelling requirements.
Nevertheless, the question remains how to achieve international harmonisation of the regulatory requirements for the labelling of IMPs.

Pages: 56,
Annexes: pages: 15