Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

A CTD FOR ASEAN –- The Harmonisation of Regulatory Aspects in the ASEAN region

Xenia Freifrau von Maltzan (Abschlußjahr: 2005)

A Common Technical Document (CTD) designed for Southeast Asia?? Is that region that important? Thereafter, how will the regulatory life in this region change?
 
This region is far away geographically and for a lot of people also imaginary. With this thesis, the understanding for the regulatory situation in the countries will be emphasized and thus this area of the world will get a bit closer in our perception.

The region has significantly gained in importance for pharmaceutical industries. In the early and late development of pharmaceutical products, it begins to play a bigger role in research activities and conduct of clinical trials. In addition to that, the international discussion about stability requirements for zone IV was highly influenced by the ASEAN view on the subject and disrupted the development to low humidity-requirements. The ICH-requirements will have to be changed after the discussion lead to a diversity of opinions. Therefore, there is a high need for the adjustment of ASEAN regulatory requirements to the international standards to avoid further discrepancies. In the future this region will have to be taken seriously in regulatory discussions to avoid disharmonisation of the requirements. Only equality of all the countries involved will avoid unilateralist leanings.

In this thesis, the focus will be on the harmonisation process of the regulatory areas, beside that the political processes in the region and the formation of the Association of Southeast Asian Nations (ASEAN) will be described. There will ge given an overview on the current regulatory situation and the reasons and driving forces in the harmonisation process. What further areas also need a harmonisation? Where did the changes take place, what are differences to the European system or the ICH-requirements? The progression of the process, the different working areas and the changes accomplished will be looked at.
Finally, the line of approach, the partners involved and the future developments in the harmonisation process will be looked upon and analysed. The thesis will highlight the impact, that the harmonisation will have on the daily regulatory life of all of those involved and critical aspects will be looked at.

Pages: 57, Annexes:9