Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Development of the ASEAN Pharmaceutical Harmonisation scheme - An Example of Regional Integration ***

Ruth Lätzel (Abschlußjahr: 2007)

Language: English

The Association of Southeast Asian Nations (ASEAN) compromising the member countries, Indonesia, Malaysia, Philippines, Singapore, Thailand, Brunei Darussalam, Vietnam, Laos, Myanmar and Cambodia was establish in 1967 to promote regional peace and stability. Chartering the new directions the ASEAN vision aims to forge closer economic integration towards building an ASEAN community by the year 2015.

The ASEANs Pharmaceutical Product Working Group is contributing to this vision by establishing the pharmaceutical harmonisation scheme. The goal is to create common regulations for pharmaceuticals in the region, reduce barriers to trade and to ensure that pharmaceutical products penetrating the ASEAN markets show sufficient safety quality and efficacy.
In my thesis I would like to explain the legal background for the establishment of harmonised pharmaceutical legislation, first experiences with the implementation and a future outlook which is the mutual recognition of marketing authorisations between the ASEAN member countries.
Finally I want to point out in the case of Singapore, how its national registration routes can serve as an example for future pharmaceutical harmonisation activities in the ASEAN region.

Pages: 44, Annexes: 4