Taiwan Experiences in International Biologics Drug Donation -Two Local Products, H1N1 Vaccine and Factor VIII and IX
Date Issued
2012
Date
2012
Author(s)
Lee, Hsin-Jung
Abstract
ABSTRACT
Introduction
Drug donation is common in international aid. To reduce inappropriate drug donations, World Health Organization (WHO) announced “ Guidelines for Drug Donations” in 1996. The contents focus on donated drug quality and communication process. However, for biologics only approved by the regulatory agency in Taiwan intending for international drug donations, there are certain barriers such as regulatory status and the unique international situation of Taiwan. By analyzing Taiwan experiences in international biologics drug donation and studying two local products: AdimFlu-s(A/H1N1) and ‘TBSF’ High Purity Factor VIII and IX Concentrate, the study is expected to explore the limitations and opportunities of Taiwan biologics intending for international drug donation activities.
Objectives
1. Analyze Taiwan experiences in international biologics drug donation
2. Study the successful case of ‘TBSF’ High Purity Factor VIII and IX Concentrate donation in contrast to the failed experience of AdimFlu-s(A/H1N1) donation
Results
AdimFlu-s(A/H1N1) for pandemic influenza and ‘TBSF’ High Purity Factor VIII and IX Concentrate for hemophilia are both valuable biologics in public health. When looking into the quality of donated products, they were manufactured under GMP standards and the regulatory bases for approvals are both line with the international practices. About the donation process, the former adopted a cooperation of government and international government organization, but unfortunately failed. However, the latter adopted a cooperation of non-government organization (NGO) in Taiwan and international non-government organization (INGO) with great help from regulatory professions and succeeded.
Conclusions
Biologics approved by regulatory agency in Taiwan actually have potential in intending international drug donation. The challenge of regulatory status should solicit support from regulatory professions. Besides, by a successful cooperation model of NGO and INGO cooperation, the possibility of successful donation will be higher.
International drug donation has been popular for years. By proactive support from regulatory professions and cooperation between NGO and INGO, local products in Taiwan are capable of successful donation. The booming pharmaceutical industries in Taiwan will have more capability to involve in this endeavor. For local pharmaceutical industries, attending for international drug donation is helpful in building international brands and establishing good images. Taiwan government could offer regulatory resources for supports and use local products as foreign aids in the future.
Subjects
drug donation
international aid
medical aid
biologics
foreign aids
SDGs
Type
thesis
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