Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Expectations of eCTD 4.0 - also a step forward for small and medium sized enterprises? ***

Dr. Claudia Heß (Abschlußjahr: 2018)

Summary
In this master thesis "Expectations of eCTD v4.0 - also a step forward to small and medium sized enterprises?" it has been examined with the help of a survey whether the planned introduction of eCTD v4.0 will be also an advantage for small and medium-sized enterprises (SMEs). The processing time was three months; it is the final thesis for the course of studies "Master of Drug Regulatory Affairs”, author is Claudia Heidi Heß.
The eCTD is now used worldwide as the standardized form of dossier submission in the pharmaceutical sector. eCTD v4.0 is considered a major update compared to the current version v3.2.2. The new version brings amongst others some fundamental changes for the user. In summary, it can be said that the main features of v4.0 are greater flexibility in granularity and new concepts for improved life cycle management.
SMEs account for majority of enterprises in the pharmaceutical sector. Due to their size and structure, on the one hand they are considered to be more risk-friendly, more effective, leaner (hierarchy, costs) and more creative than large pharmaceutical companies; on the other hand, they suffer from a thin(er) financial cover, which can significantly restrict them in many areas. As an applicant, they are also regularly using eCTD for submissions to health authorities and have to respond as fast and secure as their competitors. The survey is intended to show whether the direction in which the eCTD is developing also suits SMEs, where questions should be raised or perhaps even a change of direction should be sought.
The survey only considers user-relevant features of eCTD v4.0; in addition, questions are asked about the company's Regulatory Affairs area and the division within the pharmaceutical sector. The participants, all SMEs, came from various sectors of the pharmaceutical sector and were recruited by e-mail via mailing lists, LinkedIn posts and personal contacts. The approach chosen for the evaluation is explorative.
Twelve fully completed questionnaires are included in the evaluations. The participants come from different areas of the pharmaceutical sector (Biotechnology, Biologicals, Advanced Therapies, Small Molecules, Generics, Consultancy, drug manufacture).
SMes are looking forward positively to the introduction of eCTD v4.0. The results show that small and medium-sized enterprises are also doing well with electronic submissions. Furthermore, SMEs see the further development of the eCTD towards v4.0 as positive.
But the questions on individual features of version 4.0 give very diverse answers. This fact and comments on this indicate that individual features such as the possibility to control different lifecycles with one file seem to be not quite relevant for SMEs.
Against this background first tendencies can be seen that the further development of eCTD may pass SMEs by, at least in this survey. Some suggestions are made to counter such a direction.
The thesis has a total of 61 pages, 2 Annexes