Page 37 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

b. To maintain stringent management of pharmaceutical manufacturing, follow-up management
for modern pharmaceutical manufacturers include routine and non-periodic inspections.
Unannounced site inspections were also carried out for specific incidents (such as whistle-
blowing incidents, nonconforming products identi?ed during post-marketing quality surveillances,
and news events). Theme-based audits were also initiated to further verify the current status of
quality management in western pharmaceutical companies. On-site sampling and testing were
conducted as part of the quality monitoring process to ensure that quality of medicinal products
are maintained within the stated period of expiry.
c. As of the end of December 2015, a total of 120 modern pharmaceutical manufacturers in Taiwan
are compliant with PIC/S GMP standards (Table 2-1-1) and 893 overseas manufacturers of
imported medicinal products have been assessed as compliant. Also, by the end of December Part II - Key Administrative Results Medicinal Products Management
2015, a total of 251 foreign modern pharmaceutical manufacturers have passed on-site
inspections, ensuring a stable market supply of medicinal products.
d. To improve the quality of medicinal gases, consultation and promotion for GMP and PIC/S GMP
have been provided since 2002. Total compliance and enforcement of PIC/S GMP was achieved
st
by January 1 2014. By the end of 2015, a total of 33 medicinal gases manufacturers achieved
compliance to PIC/S GMP.
Table2-1-1 Assessment and qualification of domestic and overseas pharmaceutical companies

Total number of PIC/S GMP-compliant Total number of foreign pharmaceutical
Number of GMP-compliant domestic
Year domestic modern pharmaceutical manufacturers found to be PIC/S GMP
modern pharmaceutical manufacturers
manufacturers compliant after on-site inspections
2007 160 - 93
2008 151 - 118
2009 154 5 140
2010 155 22 157
2011 149 33 180
2012 145 44 209
2013 140 57 213
2014 98 98 246
2015 - 120 251

Note: The numbers of domestic and foreign pharmaceutical manufacturers that have passed the assessments are cumulative
every year
2. Sources Management for Modern Pharmaceutical Manufacturers
(1) The Drug Master File (DMF) system has been established to strengthen import management
for self-use active pharmaceutical ingredients (API). From October 2009 to the end of 2015,
a total of 3,690 DMF applications have completed review process. Among them, 63% were
approved, 2,323 cases were approved and 1,367 cases were rejected.

(2) To ensure the safety of drug usage for general public, TFDA has focused on strengthening the
quality management of pharmaceutical composition. Based on the promulgation on July 31,
2015, since January 1, 2016, license holders of medicinal products must provide API GMP-
compliance certi?cate to the authority; upload API source information electronically, including
manufacture name, address and country; provide API GMP-compliance certi?cate when the
application for license extension is submitted.

(3) PIC/S GMP Guide for API was adopted on May 22, 2013, and complete compliance with
GMP for API was achieved by December 31, 2015 to strengthen quality management
of API manufacturers. As of the end of December 2015, a total of 223 items from 21 API
manufacturers were found to be compliant to GMP regulations, while a total of 1,313 imported 35
API items with product license were veri?ed to be GMP-compliant.