Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Implementation of a global regulatory change control process – challenge and chance for a generic pharmaceutical company "Definition of a regulatory change control process taking different regulatory requirements regarding change control of different countries (e.g. differences within EU vs. US) into account to ensure a constant supply chain" ***

Alexandra Zoller (Abschlußjahr: 2013)

Summary
Language: English
When setting up a change control process, a generic company has to take into consideration a complex regulatory framework. The legislation in Europe has been subject to a harmonisation process during the last years and the implementation of the new variation guideline was a major step forward. Nevertheless, the administrative burden for minor changes which does not affect the quality, safety and efficacy of the product is still high and requires an intensive tracking. As some important issues like sell- off period etc. are either regulated only nationally or not at all, a proper planning of a change takes enormous effort, even it is only a minor one.
As the globalisation is going on, a change control process has to suit the needs of other regions, for example the requirements of the US legislation as well.
The legislation regarding post-approval changes in the US is similar to the EU requirements at a first glance. However, having a deeper look at the guidelines you will recognize that requirements regarding documentation and bioequivalence studies differ. In addition, the review timeline especially for major changes differ extremely. This makes a globally harmonized change procedure very difficult to handle, especially in those situations in which a product developed for the global market has to face profound changes, as for example a change to a new production site.
The recent introduction of the ICH guidelines Q8, Q9, Q10 and Q11 offers new opportunities for a lean change control process. However, they require a more detailed and thus a longer lasting and more cost effective development phase. Both cost and time are two important factors in the generic industry. Up to now, there is only very limited experience if an "enhanced approach" in development results in a remarkable reduce of workload and costs when it comes to post-approval changes.
Further, due to the first launches of biosimilars during the last years these products will become part of the change control process as well. The complex nature of these products and the specific needs to prove comparability to the "old" product are further challenges generic companies have to cope with.          
The allocation of the different stakeholder of a global change control process has to be done very carefully. To set up one common global change control process which suits all the needs is nearly impossible and the definition of the process should be based on the development approach used. Products which have been developed for the global market require globally acting functions whereas products which have been developed for one region only need to have regional actors as overlaps are only marginal.
A further harmonisation of the legislation on the one hand and a reasonable use of the possibilities provided by the regulations on the other hand would help to decrease the workload for all parties involved.
Pages: 46; Annexes: 2