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Since 1997, clinical
trials conducted in Taiwan must comply with the Good Clinical Practice
(GCP) guidance published by the Department of Health (DOH). This guidance
was revised in 2002 to be consistent with the ICH guidelines. There
is a routine GCP inspection system and almost all clinical trials
are inspected by the health authority.
Before a clinical trial can commence, approval of the clinical trial
protocol has to be obtained from the Institutional Review Board (IRB)
of the individual hospital. In 1997 a joint Institutional Review Board
(JIRB) was established by the DOH to review clinical trial protocols
for multicentre trials. The average protocol review time at the JIRB
is about 25 working days.
The clinical trial protocol must also be approved by the Department of Health. Parallel submission to IRB and DOH is possible in order to save time. The average protocol review time at the DOH is about 30 days. If there are controversial issues, more time may be required. The Bureau of Pharmaceutical Affairs at the DOH is responsible for reviewing the clinical trial protocols; it is assisted by the Center for Drug Evaluation, a non-governmental, non-profit organisation established by the DOH in 1998.
 Health
Care System
Taiwan has a population of about 23 million people. A National Health
Insurance Program was implemented in 1995 to provide all citizens
with equal access to health care.
Clinical
Trials Management
At ECRON/PPC our clinical research associates (CRAs) and clinical
research coordinators (CRCs) are highly trained, using time-proven
procedures, in the knowledge of Good Clinical Practice (GCP) and regulatory
requirements as well as clinical practice training. They have demonstrated
consistent abilities to effectively communicate in both Chinese and
English to enhance team, site and client relations, using state-of-the-art
technology, and applying globally accepted standards in the clinical
trial management.
Our highly qualified and experienced team based in Taipei is specialised
in the management of international clinical studies in various phases.
Central
Laboratory
With international quality management system and technology, ECRON/PPC
Central Laboratory strives to create the environment of high quality
and valuable service to achieve customer satisfaction.
To further fulfil its dedication to providing world-class services,
in the fourth quarter of 2002, PPC Central Laboratory became the
first CAP (College of American Pathologists) accredited clinical
central lab in Taiwan and the first in Asia to have both the CAP
and the COLA (Commission on Office Laboratory Accreditation- US)
qualifications.
PPC
and ITRI announce strategic alliance
27 November, 2003
Taiwan's Industrial Technology Research Institute (ITRI) and local
contract research organisation Protech Pharmaservices Corporation
(PPC) announced today that the two groups had recently signed a
strategic alliance with the aim of promoting herbal medicine new
drug development and helping local companies enter the global pharmaceutical
market.
As PPC is the first such Taiwanese company to pass both College
of American Pathologists (CAP) and Commission on Office Laboratory
Accreditation (COLA) certificates, it is considered well qualified
for conducting multinational clinical trials. As for what ITRI brings
to the alliance, the institute has a drug development pipeline focused
on anti-cancer treatment, as well as drugs for hepatitis and asthma.
Local
office/staff
ECRON / PPC
4th Floor, No. 360, RueiGuang Rd., Taipei, Taiwan 114
Phone: +886- 2-2657-7777 Fax: +886- 2-2799-3366
Email: HQ@ecron.com
Authorities
Department
of Health, Taiwan, R.O.C.
Bureau of
Pharmaceutical Affairs (BPA)
Center for
Drug Evaluation (CDE)
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TAIWAN
