Food and Drug Administration
(3) In 2014, a total of 49 nonconforming imported food from Mainland China was reported. The causes
of the nonconformities, in descending order of incidence, were 31 cases of pesticides, six cases of
preservatives, five cases of animal medication, four cases of heavy metals, one case of other causes,
one case of antioxidants, and one case of melamine.
3. Harmonization of Regulations and Standards
(1) Through their liaison windows, Taiwan and Mainland China announced revisions of food additive
standards and the food safety and sanitation standards. Both sides made 21 announcements on the
food additive standards and 2 announcements on the food safety and sanitation standards in 2014.
(2) The comparison of differences between the technical requirements in the
Pharmaceutical Affairs Act
of Taiwan and the newly revised Medical
Device Supervision Regulation
of Mainland China as well
as five specific medical device standards for infrared lamps and clinical electronic thermometers was
completed in 2014.
(3) TFDA held a
Seminar on Regulations Governing Cosmetic Exports to Mainland China and Actual Case
on 4 January 2014. Personnel from the China Food and Drug Administration (CFDA) were
invited to Taiwan in order to introduce regulatory policies and provide instructions on permit application
for Taiwan business firms.
(4) TFDA also organized a
Cross-Strait Conference on the Management of Food Nutrition Labels
on 20 May 2014. Experts from competent authorities discussed and exchanged ideas on nutrition
labeling regulations to achieve mutual understanding, these are taken as references for establishing
relevant regulations in the future.
(5) Personnel from CFDA were invited to Taiwan for the joint Good Clinical Practice (GCP) inspection
exchange program from 20-23 May 2014, and visited Taiwan's clinical trial centers to gain a deeper
understanding of clinical trial institution management and GCP inspection systems from both sides.
Differences of GCP regulations and inspection practices between both sides, and the future possibile
collaborations in DCP inspections were disscussed.
(6) In 2014, names and technical terms in the appendix/general provisions of pharmacopoeias in both
Taiwan and Mainland China were compared. Priorities included comparisons and harmonization of
testing methods and standards for common tests in order to establish the feasibility of simplifying or
exempting pharmaceutical testing in both Taiwan and Mainland China.
(7) The Third
Cross-Strait Technical Exchange and Conference for Medicinal Product Testing
in Fuzhou, Mainland China from 4-6 November 2014 (Figure 9-7) to present and discuss testing
techniques for medicinal products, medical devices, health foods, and cosmetics. The purpose of the
conference was to encourage mutual acceptance and recognition of future testing capabilities.
4. Cooperation on Research and Development
(1) Accelerating Time-to-Market for Products Made in Taiwan
a. Since 2012, TFDA has continuously requested the CFDA to authorize provincial and city-level drug
administration agencies to review medical devices already approved for market sales in Taiwan.
promotion of CFDA authorization of provincial and city-level drug administration agencies to
review medical devices
from Taiwan remained listed as a key topic for future implementation.
b. After the July 2012 exchang on administrative regulations of cosmetic products, both Taiwan and
Mainland China immediately exchanged comparative study results to discuss collaboration of
testing agencies on both sides of the Strait with the hopes of accelerating the acquisition of test
permits of cosmetics made in Taiwan and reduce the time-to-market of such products in Mainland