Page 43 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report Chapter 3. Source and Manufacturing Management

Section 2. Medicinal Products and Cosmetics

Manufacturing Management

Current Status

To ensure the stable production and management of medicinal products and
cosmetics are maintained, a source management system has been enforced in Taiwan to
assist manufacturers in improving product quality. A systematic management to align
with international GMP regulatory mechanisms for medicinal products and cosmetics
were also employed to allow the industry to export their products to the international
market. Controlled drugs are subject to the provisions of “Controlled Drug Act” and
“Good Manufacturing Practice” for related matters to enhance manufacturing quality of
controlled drugs and control the directions of the drugs.

Policies and Outcomes

1. Medicinal product manufacturing management
(1) Medicinal product management
A. Establish “Drug Master File (DMF) system” for active pharmaceutical ingredients

import and self-use. From October 2009 to 2016, a total of 4,498 DMF
applications are received, of which 3,038 have been approved while 1,460 are
rejected. The approval rate is 67.5%.
B. Starting from January 1, 2016, medicinal products should use APIs which are in
compliance with GMP, and the source data should be declared electronically.
Until December 31, 2016, the declared rate has achieved up to 100%, besides the
manufacturing or imports of drug products prohibited.
C. Promulgate GMP Standards for API on May 22, 2013(Pharmaceutical Inspection
Co-operation Scheme: Good manufacturing practice, PIC/S GMP) has been fully

implemented at the end of December, 2015. Until the end of December, 2016, a
total of 245 items in 24 domestic API manufacturers have met GMP regulations
for API. The total number of API import permit licenses for GMP reference are
1,531, accounting for 75.5% of total permit licenses.

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