Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Comparison of the labelling processes of human and veterinary medicinal products with an emphasis on the development and post-marketing maintenance activities of labelling

Dr. Awinder Sohal Kauselmann (Abschlußjahr: 2014)

Summary
Language: English
Labelling of medicinal products is an area that has become more demanding due to increasing regulatory scrutiny with added compliance risks. Managing global markets with diverse national regulations is challenging for any pharmaceutical company. The labelling process itself is also relatively complex because labels and their variations need to be implemented and often harmonised across different countries with different labelling regulations worldwide. New legislations and policies emphasise the need for companies to have an end-to-end oversight of the labelling process from safety signal confirmation to the package/label text change, and this applies to both human and veterinary medicinal products. Recently there has been an increase in the number of requests from competent authorities regarding labelling particularly due to globalisation, which has resulted in a shift towards more complex regulatory procedures. This is a wake-up call to pharmaceutical industries to adapt their internal processes and cultures to meet the requirements of key emerging markets. The main shift in the regulatory environment has been more focus on public and animal safety, both pre- and post-approval of drugs, and the introduction of new internal policies and regulatory governance bodies. There is currently a huge administrative burden on label requirements both in the EU and globally, which is very costly and impractical, particularly for smaller markets. To overcome such problems, legislation reviews have outlined the need to reduce the administrative burden in several key areas including labelling requirements. In addition, extensive research has been carried out by various groups to determine the important practical aspects of labelling of human and veterinary medicinal products. This research has particularly highlighted the importance of readability issues of the package leaflet to avoid medication errors and to further improve patient compliance. Since public safety is paramount for pharmaceutical industries and regulatory bodies, both must ensure that thorough quality control of drugs, in terms of safety, efficacy and quality, as well as clear labelling are being implemented.
In this work the labelling legislation and labelling processes of human and veterinary medicinal products have been compared and discussed. We have seen that there are more similarities than differences in the labelling legislation and process between the veterinary medicinal products (VMPs) and human medicinal products (HMPs).
The main difference between the two processes is that the VMP process as used by Bayer Animal Health (BAH) is more fragmented than the HMP process. In BAH different project teams as well as the label management team take responsibility for different parts of the process. The BAH label management and safety teams are actively involved in the early part of the process up to the point where the new label is submitted to the authorities. However, the project responsible person and the project teams take a more active role in aspects such as preparing and updating the Summary of Product Characteristics (SmPC), preparing the company safety data sheet (CSDS) and implementing the artwork and supply chain. The labelling team at BAH is also not responsible for technical and non-safety changes as these are the responsibility of the Analytics, Product Supply and Change Management departments. In the HMP process however, the labelling team is actively involved throughout the process. The main advantage of the fragmented process at BAH is the increased flexibility and therefore efficiency of the process, but a disadvantage of this model is communication problems that arise between different teams.
The challenges facing both VMPs and HMPs have been identified as: the high cost of labelling requirements in smaller markets, the problems with harmonisation of labelling text during national implementation, the administrative and practical burden of updating and maintaining a label world-wide, the impracticality of labelling requirements for multi-language labels due to space constraints and the readability challenges of the package leaflet.
As a case study, the BAH labelling process has been compared to a generic human medicinal product labelling in the context of post-marketing maintenance of labelling activities. My recommendations to BAH to further improve its labelling activities have also been discussed.
In conclusion, the BAH labelling process functions comparably with the human process despite the huge difference in resource availability and the burdens associated with operating in smaller markets.
Pages: 54