Page 100 - 2018食藥署年報(英文版)

2. Becoming international laboratories

The General European OMCL Network (GEON), which was jointly established by the
EU Commission and the Council of Europe in 1994, enhanced the ability of members to control
over the quality of medicinal products by technical and information sharing. At present, official
laboratories of the European Union, Canada, and Australia, and other countries have followed one
another to become a member.
Section of Biologics, Research and Analysis of TFDA has been assigned a priority to apply
for membership of the General European OMCL Network (GEON). Through rigorous dossier

review and on-site audit procedures by EDQM experts, TFDA has finally been officially notified
as an associate member of GEON, and become a recognized international laboratory (Figure 6-7),
which could allowed for information exchange and resource sharing among the networks.

Figure 6-7 OMCL certification of internet quality
management control system

3. Future plan and goals

TFDA will continue to take part in the In-network inspection method development, and
inspection capability testing activities, as well as sharing post-market monitoring result, and

cooperating with laboratory testing technology such as pharmaceuticals and cosmetics in the
network to boost participation in international research opportunities for testing methods and
standards. By keeping in touch with the international contacts, we are able to improve the quality
and professionalism in regards to the national laboratory inspection techniques.
In order to meet the challenges in the future and enhance the safety of food safety, TFDA
strived for Executive Yuan’s approval on “Explanation of the National Food Laboratory and the
Education and Training Building Project” and the “Enhanced Central Food Safety Inspection

Capacity” to incorporated into the prospective “Food safety construction design.” The High-
order detection equipment such as Fourier transform mass spectrometry and nuclear magnetic
resonance instrument and other high technologies were introduced to the laboratory, providing a
fully equipped internationalized facilities, simultaneously allowing the site to be a training center
for the Department of Health and local inspection personnel, as well as completing food and drug
safety network at national aspect, local level and civil independent inspection.

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