Page 48 - 2019食藥署年報(英文版)

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In order to strengthen the safety and quality of drugs, we carried out the safety analysis and
evaluation of drugs based on the drugs with safety concerns. The drug safety reassessment for a
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package insert, restricted usage were adopted for 16 drugs, for example: we continued to
implement the drug risk management plan for drugs that contain carbamazepine ingredient and

published a risk communication form of drug safety information, to enhance the effectiveness of
risk management and control as well as to ensure the safety of drugs for the public.

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In 2018, the usage amount of the platform was 13,000 person-times, among them, the drug
dosage, adverse reactions and recommendations for pregnancy and breastfeeding are mainly
inquired. In order to improve the query skills, TFDA held three training courses in southern,
northern and central Taiwan. The courses invited pharmacists to share user experience, talk

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service capacity in the clinics and community pharmacies.

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The purpose of implementing the Good Distribution Practice (GDP) is to ensure that the
drug is in compliance with the Good Manufacturers Practice (GMP) from the production stage
to distribution process.
There are many global organizations and countries have started to implement drug
GDP, including the World Health Organization, the European Union, Singapore, Malaysia,

the U.K., Germany, Switzerland, the United States and Australia. The Pharmaceutical
Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) also
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the international implementation standard for drug GDP. Therefore, TFDA implements the
distribution and quality management of drug by promoting the GDP system that meet the
international standards, to ensure the safety of drugs, improve the distribution quality of drugs
and create international competitiveness.

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