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National Laboratory of TFDA has been officially notified to be an associate member of General European Official Medicines Control Laboratory Network, being an internationally recognized laboratory 【Date:2018-03-15】 unit:研究檢驗組

Taiwan Food and Drug Administration (TFDA), Division of Research and AnalysisSection of Biologics has been officially notified to be an associate member of General European Official Medicines Control Laboratory Network (GEON) on March 2nd, 2017 by European Directorate for the Quality Medicine & HealthCare, the Council of Europe (EDQM). This honor specifies that TFDA National Laboratory in the field of quality control of vaccines and other biologics for human use has been internationally recognized. In the future, TFDA will continually strengthen our capability to improve medication safeguard by information exchange and resource sharing in the network.

The Commission of the European Union (EU) and the Council of Europe created a network of official medicines control laboratories (OMCLs) in 1994. The network is composed of the full member (EU member) and the associated member (non-EU member). The member in the network could continually upgrade the levels in controlling the quality of medicinal products by the information exchange and resource sharing of testing method development, capability testing, and post-marketing surveillance. The official laboratories of EU, Canada, Australia have joined the OMCL network, becoming a member of GEON.

       TFDA is responsible for quality control of biologics. In accordance with the article 74 of Pharmaceutical Affairs Act, the lot release system is performed in the field of vaccines and other high-risk biologics for human use. Most of the vaccines for human use in Taiwan come from Europe country. TFDA has participated in International Collaborative Study to establish the WHO International Standards about twenty times, and also positively participated in the collaborative study on testing method and reference substance hosted by the Groups of Experts of European Pharmaceutics. Furthermore, the TFDA Division of Research and AnalysisSection of Biologics applied for membership of GEON in 2016. Through rigorous dossier review and on-site audit procedures by EDQM experts, TFDA has finally been officially notified to be an associate member of GEON. Followed by Singapore's Health Science Authority, TFDA becomes the second official laboratory in Asian countries to join this network. TFDA still strives to expand other pharmaceutical filed of laboratory attestation to improve medication safeguard.