Abstract
This research seeks to fill the gap in knowledge on pharmaceutical registration policy in Thailand, by
using a mixture of public and health policy analysis and technical aspects, and focuses on content,
context, actor and process. The two specific questions are; (a) what is pharmaceutical registration
policy in Thailand? (b) What are the factors influencing the pharmaceutical registration policy process?
The thesis focuses on both policy development and the implementation process.
The objectives of pharmaceutical registration policy in Thailand had been found to be unbalanced;
focusing more on access and obscuring the general goal of quality, safety and efficacy. A survey of
tracer drug registration (1983-1997) found that the registration system in Thailand has double
standards between new and non-new drugs, with little success in re-evaluation of previous registered
drugs. The research showed a large variation in registration time (1-2147 days), a high number of
approved drugs, contrasted with few rejected or withdrawn. Hence the Thai registration system may
be described as ‘entrepreneurial and permissive’ or as taking a ‘laissez-faire’ approach.
This research has identified four main groups of factors that led to the failure of implementation. First,
policy on registration was not well developed because of the unbalanced influences of different actors
with varying powers; this was reflected too in the implementation process, which was also influenced
by a variety of actors. Second, there are continuing technical weaknesses in the drug regulatory
structure and process. Third, the advisory consultative process in the registration system was not well
managed. Fourth, key actors’ attitudes and perceptions, and organisational hierarchy had an important
influence on decision-making. On the basis of the understanding of these weaknesses, it may be
possible to introduce new potential measures in the future.
