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2014 Annual Report
After that, three documents were published regarding the international
guidelines for in vitro diagnosis medical devices. These documents were
published by a Taiwan-championed work group, named as WG1a. The
documents later were endorsed by the AHWP and became official AHWP
documents. Research funds from the Bill & Melinda Gates Foundation were
received to host on international IVD medical devices meeting in 2013.
b. In 2013, TFDA continued to participate in the APEC Life Science Innovation
Forum Planning Group (LSIF-PG) meetings and Regulatory Harmonization
Steering Committee (LSIF-RHSC) meeting. TFDA championed two priority
work areas, including
“
Good Review Practice
”
(GRevP) and Combination
Products in RHSC.
(4) The cosmetic regulations will be amended to align with the international trends
Taiwan government is working on amending cosmetic regulations in order
to harmonize with the international regulations and keep the communication
channels open for the industry.
4. Vertical Alliance on Drug Abuse Prevention
In accordance with the provisions of international conventions, TFDA rigidly
follows the written instruction for all the import and export control drugs required
documents. International cooperation was emphasized. Safeguarding the
distribution of legitimate controlled drugs is our mission. In 2013, 21 out of the
The AHWP WG1a-PAHWP-LSHTM Joint Conference on International IVD Medical Devices Regulations