Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory requirements for clinical trials in Singapore, Hong Kong, Taiwan and South Korea -hurdles and opportunities, and development strategies

Ariane Wölfer (Abschlußjahr: 2013)

Summary

Language: English

One of the purposes of this paper is to outline the regulatory requirements for clinical trials in the so-called Four Asian Tigers -Singapore, Hong-Kong, Taiwan and South Korea. These countries should be seen as a good example for the development of drug regulatory systems in countries outside the EU and US. This thesis shows that there are parallels between regulatory procedures among these countries in terms of timelines and submission procedures to the authorities and ethics committees. This can be attributed to infrastructrural development and recent reorganisation of their relevant authorities. The governments of the Four Asian Tigers strongly promote the healthcare sector which in turn has led to the advancement of pharmaceutical research centres.

Fundamental aspects have to be taken into consideration when conducting clinical studies in order to overcome existing hurdles and take advantage of inherent opportunities. The legal framework is the basis for a proper trial implementation and the protection of patients. With regard to the authorities’ capacities there might be differences, e.g., in their timelines. Due to differences in medical standards and infrastructure, the sponsor has to ensure the protection of trial volunteers by means of detailed criteria in the protocol and through monitoring of the trial sites. Regarding cultural differences in global clinical research, a pivotal aspect is the need for local contacts. The cooperation with CROs with their local expertise could help to overcome cultural hurdles. The main task for authorities, on the other hand, is increased international cooperation in the regulation of clinical trials, making cross-border agreements between regulatory bodies necessary. The description of the use of bridging studies is necessary in order to allow extrapolation of foreign clinical data to a new region so that the number of clinical studies required can be reduced. Continous efforts should be undertaken by both governments and the industry to further improve the environment, infrastrucure, and cababilities for clinical studies in that region.

Pages: 59