Page 98 - Taiwan Food and Drug Administration 2016 Annual Report

Taiwan Food and Drug Adminstration

2. Medicinal Products
(1) TFDA organized the International Conference on Illegal Medicines and Adulterated Dietary
Supplements from September 1 to 2, 2015 (Figure 2-8-8). Experts, academicians, and
representatives of official agencies and industrial associations from the US, the EU, Japan,
Singapore, South Korea, and Malaysia were invited to Taiwan to share experiences on
testing techniques and management of illegal drugs. The President himself gave a message
commending the Conference, helping to greatly improve the prestige of the event.

(2) TFDA attended the 2015 US Pharmacopoeial Convention from April 22 to 26, 2015 to discuss
key guidelines of the US Pharmacopoeia (USP) from 2015 to 2020 and other topics such as
increased collaboration between the USP Convention with TFDA, modernization of specific
medicinal products, and improvements to food safety to achieve bilateral collaboration.
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(3) TFDA participated in the 1 European Pharmacopoeia Commission meeting session of 2015
from March 15 to 16, 2015 as an observer of the European Directorate for the Quality of
Medicines & HealthCare (EDQM) of the Council of Europe in order to gain an understanding
of the compilation, key focuses, and operational models of the European Pharmacopoeia,
and to exchange opinions on medicinal product quality and testing techniques with various
representatives around the world.
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(4) TFDA attended the 8 Edition of the European Pharmacopoeia Training Session - Chemicals of
the EDQM from July 9 to 10, 2015 in order to acquire lessons on the compilation and revision
of the European Pharmacopoeia, formulation of analytical methods and specifications for
impurities in drugs, preparation of standard samples, and suitability of the Certi?cate European
Pharmacopoeia (CEP) for active pharmaceutical ingredients (APIs).
(5) TFDA visited the National Institute of Health Sciences (NIHS) of the Ministry of Health, Labor
and Welfare (MLHW) of Japan during November 10 to 19, 2015, and carried out a series
of on-site technical studies at the laboratories of Division of Pharmacology and Division of
Biomedical Food Research (including illegal drugs) to investigate the practice of medicinal
product quality evaluation and research, quality management of traditional Chinese medicinal
preparations, current state for the management of abused drugs, identi?cation and analysis
of unknown materials, and identi?cation of the botanical sources for biomedical products in
Japan.
(6) TFDA was invited to participate in collaborative studies for international standards that included
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the 4 WHO International Standard for Streptomycin, 5 WHO Hepatitis C Virus for NAT-based
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assays, and 1 WHO International Standard for anti-EV71 serum.
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(7) TFDA attended the 20 anniversary meeting of the Standardisation of Genome Ampli?cation
Techniques (SoGAT) in June 2015, to understand the process of establishing international
standards of WHO which could then be used to establish standards for blood-borne
pathogens in Taiwan.
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(8) In September 2015, TFDA attended the 1 Asia Lab-Net workshop organized by the National
Institute of Food and Drug Safety Evaluation (NIFDS) of South Korea (Figure 2-8-9), and gave a
speech sharing management experiences of lot release of biologics in Taiwan, helping various
countries to achieve better understanding on the details of the lot release management system.
(9) US Pharmacopoeia committee member Dr. Edith Chang Yu-Wen was invited to give a speech
on Experience Sharing and Process of the Standardization of Biopharmaceuticals in the US
Pharmacopoeia (Figure 2-8-10) to achieve better understanding of the compilation of USP,
96 preparation of standards, and standardization of emerging technologies and products. These