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Food and Drug Administration


(3) Monitoring of Global Medicinal Product Quality Alerts

Global medicinal product quality (recall) alerts are monitored on a daily basis for immediate tracking and

initiating recalls of medicinal products when necessary. In 2014, a total of 656 global medicinal product

quality alerts was monitored. Of these, nine medicinal products had beenimported into Taiwan and were

subsequently recalled. The manufacturers also provided continuous active notification of the incident and

conducted relevant recalls.

(4) Biological Products Lot Release

381 batches of biological products lot releases have been implemented. A total of 12,616,466 doses

was approved and released, while eight batches were blocked (for about 53,385 doses) due to

transport temperature nonconformities.

(5) In 2014, illegal pharmaceutical additives to weight loss or virility products were monitored. A total of 109

capsules, tablets, and powdered foods were sampled from drugstores, pharmacies (drug stores), and

distributors. Of these, two were found to have pharmaceutical contents. Another three were found to

contain ingredients not indicated on the label. All these cases were transferred to the relevant county- or

city-level health agencies for further handling.

2. Medicinal Product Distribution Management

(1) Medicinal product quality requirements of national health authorities from around the world have

expanded from the traditional production-aspects characterized by the Good Manufacturing Practice

(GMP) to the distribution aspects governed by the Good Distribution Practice (GDP). The main

purpose of this expansion is to avoid storage, transport, and distribution processes from affecting

medicinal product quality and ensure drug-use safety for consumers.

(2) Many countries and organizations around the world, including the World Health Organization

(WHO), the European Union (EU), the United States, Singapore, Malaysia, Mainland China, Australia,

Canada, and Japan have stipulated laws related to GDP for medicinal products to establish relevant

regulation and management measures. Additionally, the Pharmaceutical Inspection Convention and

Pharmaceutical Inspection Co-operation Scheme (PIC/S) also promulgated its own GDP Guide on

1 June 2014. All of these measures demonstrate the importance placed on the management of

medicinal product distribution.

(3) To ensure the comprehensiveness of the medicinal product quality management system throughout the

entire supply chain, TFDA promoted a medicinal product distribution management system in Taiwan

since 2011, started from 2012, TFDA conducted GDP gap assessment visit to the companies applied for

consultation. By the end of 2014, a total of 95 pharmaceutical manufacturers, agents, and logistics related

companies for a total of 190 sites have undergone consultation visits, of which 78 companies were given

the rating as


. During this period, TFDA also held training activities as information sessions,

forums, technical seminars, and on-site demonstration, to improve distribution/transportation service

providers' awareness and understabnding of the concepts of medicinal product quality management.

(4) Referenced from the details of PIC/S GDP for medicinal products, TFDA announced a draft of

guidelines for Taiwan's GDP for medicinal products in order to provide businesses with GDP

standards for reference purposes. In the future, TFDA will continue to promote legislation for GDP

system to ensure the comprehensiveness of medicinal product supply chain management systems.

3. Suppression of Illegal Medicinal products, Food Products, and Cosmetics

(1) Integrating Resources Across Multiple Departments and Strengthening the Prohibition of Counterfeit

and Inferior Drugs