• TH
    • EN
    • Register
    • Login
    • Forgot Password
    • Help
    • Contact
  • Register
  • Login
  • Forgot Password
  • Help
  • Contact
  • EN 
    • TH
    • EN
View Item 
  •   Home
  • สถาบันวิจัยระบบสาธารณสุข (สวรส.) - Health Systems Research Institute (HSRI)
  • Research Reports
  • View Item
  •   Home
  • สถาบันวิจัยระบบสาธารณสุข (สวรส.) - Health Systems Research Institute (HSRI)
  • Research Reports
  • View Item
JavaScript is disabled for your browser. Some features of this site may not work without it.

Pharmaceutical registration policy in Thailand : development and implementation

นิยดา เกียรติยิ่งอังศุลี; Niyada Kiatying-Angsulee;
Date: 2543
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a large variation in registration time (1-2147 days), a high number of approved drugs, contrasted with few rejected or withdrawn.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.
Copyright ผลงานวิชาการเหล่านี้เป็นลิขสิทธิ์ของสถาบันวิจัยระบบสาธารณสุข หากมีการนำไปใช้อ้างอิง โปรดอ้างถึงสถาบันวิจัยระบบสาธารณสุข ในฐานะเจ้าของลิขสิทธิ์ตามพระราชบัญญัติสงวนลิขสิทธิ์สำหรับการนำงานวิจัยไปใช้ประโยชน์ในเชิงพาณิชย์
Fulltext
Thumbnail
Name: hs0810.pdf
Size: 2.167Mb
Format: PDF
Download

User Manual
(* In case of download problems)

Total downloads:
Today: 0
This month: 0
This budget year: 1
This year: 1
All: 63
 

 
 


 
 
Show full item record
Collections
  • Research Reports [2469]

    งานวิจัย


DSpace software copyright © 2002-2016  DuraSpace
Privacy Policy | Contact Us | Send Feedback
Theme by 
Atmire NV
 

 

Browse

HSRI Knowledge BankDashboardCommunities & CollectionsBy Issue DateAuthorsTitlesSubjectsThis CollectionBy Issue DateAuthorsTitlesSubjectsSubjectsการบริการสุขภาพ (Health Service Delivery) [619]กำลังคนด้านสุขภาพ (Health Workforce) [99]ระบบสารสนเทศด้านสุขภาพ (Health Information Systems) [286]ผลิตภัณฑ์ วัคซีน และเทคโนโลยีทางการแพทย์ (Medical Products, Vaccines and Technologies) [125]ระบบการเงินการคลังด้านสุขภาพ (Health Systems Financing) [158]ภาวะผู้นำและการอภิบาล (Leadership and Governance) [1281]ปัจจัยสังคมกำหนดสุขภาพ (Social Determinants of Health: SDH) [228]วิจัยระบบสุขภาพ (Health System Research) [28]ระบบวิจัยสุขภาพ (Health Research System) [20]

DSpace software copyright © 2002-2016  DuraSpace
Privacy Policy | Contact Us | Send Feedback
Theme by 
Atmire NV