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2014 Annual Report
(2) By complying with four indexes, Innovative, Contributive, Effective and Satisfactory
stages as screening criterion, TFDA expedites the process to support manufacturers
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(3) In 2013, TFDA helped 27 projects to meet R&D milestones, which comprise 2 new
drug approvals, 3 new drug applications, 7 each of phase II and phase III clinical trials,
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meetings, offering customized advices suited to their current product development and
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Section 2 Drug Product Sources Management
Status
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“
Good Manufacturing Practice, GMP
”
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reinforced
“
current Good Manufacturing Practices, cGMP
”
, and simultaneously
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announced the GMP standard of the
“
Pharmaceutical Inspection Convention and
Pharmaceutical Inspection Cooperation Schemes, PIC/S
”
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Besides pharmaceutical manufacturers, manufacturers of medicinal gases and
active pharmaceutical ingredients were also included in the management of GMP for
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Policy and Outcome
1. Complete the Complying Process of PIC/S GMP for All the Pharmaceutical
Manufacturers
(1) Promotion of PIC/S GMP
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made an announcement that any pharmaceutical manufacturer noncompliant with
PIC/S GMP after the time limit will be forced to cease the manufacturing of medicinal
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