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Food and Drug Administration
(4) In June 2013, TFDA was invited to
“
The 7
th
Asian World Vaccine Congress
”
conference.
A keynote speech, titled as
“
Advancing Regulatory Convergence with international
standards in Asia.
”
was delivered.
(5) In May 2013, TFDA joined the internship for the
“
Drug Dissolution Theory and
Methodology training
”
, as part of the USP training program.
(6) In September, 2013, the National Pharmaceutical Control Bureau (NPCB), Ministry
of Health, Malaysia, dispatched three officers to TFDA for a three-weeks training,
the program related to the vaccine quality control testing, document reviewing,
and inspecting.
3. Medical Devices Sector Industry
In September 2013, TFDA visited the Terumo medical device, Mitutoyo instrument
manufacturing factories and Japan International verification unit JFE Techno-Research
(JFE-TEC) for knowledge sharing. Scientists and technology researches from Taiwan and
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Section 3 Cross-Strait Exchanges
Ever since
“
Cross-strait Agreement on food safety
”
singed on November 4, 2008, TFDA
and its Mainland counterparts have convened
“
expert meeting of competent authorities
”
and
“
Import and Export Food Safety Meeting
”
each year to emphasize and exchange
major concerns in food safety standards and risk communication. With regards to the
medical products, another agreement, named
“
Cross-strait Agreement on medical and
health cooperation
”
, was met on December 21, 2010, and on the basis of this Agreement,
TFDA and CFDA have built up a working group to promote cooperation on product
management, research and development.
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including food, medicines, medical devices, health food and cosmetics in accordance
with the agreements and established a communication platform and rapid notification
mechanism. Furthermore, TFDA also entrusted Center for Drug Evaluation (CDE) with pilot
programs for cross-strait cooperation on review procedures.
In 2013, TFDA continued unremitting technical exchange and comparison on laws and
regulations between cross-strait. In order to accelerate the listing progress of Taiwanese
products, TFDA successfully facilitated CFDA to establish a single consultation window
for Taiwan manufacture
’
s inquiries. TFDA plans to focus cooperation on simplifying the
approval process in the early next year.