Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory considerations in cooperation of small and medium-sized enterprises with their foreign business partners regarding marketing authorisation applications for herbal medicinal products ***

Ute Scheibel (Abschlußjahr: 2017)

Summary
Language: English
Obtaining and maintaining marketing authorisations (MAs) for HMPs (herbal medicinal products) is a very complex and challenging project. Especially SMEs (small and medium-sized enterprises) do not have the same financial and personal resources available like global companies do. Global companies have affiliates spread throughout the world contrary to the SMEs who must find suitable BPs (Business partners). The working procedures of SMEs with BPs are completely different compared to global companies with affiliates, e.g. a SME cannot act as a parent company and simply hand over working processes and instructions to the BP. Contrary to the working procedures of global companies, the BP and the SME function as a cooperation. They are both equal partners, and acceptable compromises must often be sought. Especially the distribution of responsibilities and the resulting tasks are major topics at the start of a project. A carefully planned and conscientiously considered assignment of responsibilities before the projects starts contributes to the success of obtaining a MA in a timely manner, which will also have an impact on the financial aspects.
Therefore, the SME must carefully consider and discuss with the BP how and which responsibilities and respective tasks can be assigned to whom. Also, different national laws or guidelines must be taken into account. Since it takes some time to understand the requirements and to fully realise the consequences, the SME should be informed about national particularities as early as possible before the project starts. Additionally, the implementation of the necessary requirements and corresponding structures might take some time. Only if the SME knows the requirements, the conditions and the consequences the discussion about sharing of responsibilities can be successful. It is absolutely crucial, that no topic is forgotten. An optimal organisation can save time and costs.
This thesis presents some important considerations and questions regarding responsibilities from the drug regulatory affairs point of view, which should be raised by the SME and discussed with the BP. Moreover, it gives some suggestions on how the responsibilities and tasks could be shared between the SME and the BP and points out peculiarities and difficulties. Examples of differing requirements and distinctions depending on individual countries were given to support the importance of the addressed responsibility. At the end of this thesis, there is an exemplary checklist with topics and questions that should be considered. This checklist might help to erase mistakes and keep up with key issues.
Pages: 103,
Annexes: 6, Pages: 21