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Food and Drug Administration


Section 2 Medicinal Products Source Management

Current Status

To improve medicinal product manufacturing quality and follow international standards, Taiwan has

imposed increasingly stringent management aligned with international regulations over modern

pharmaceutical dosage forms manufacturers. Since 1982, Taiwan has promogated Good Manufacturing

Practice (GMP) regulation, then in 1995, promoted current Good Manufacturing Practice (cGMP)

while developing dynamic cGMP management models aligned with global trends. Starting in 2007,

Taiwan also began implementing the GMP standards of the Pharmaceutical Inspection Convention

and Pharmaceutical Inspection Co-operation Scheme (PIC/S). As of 31 December 2014, PIC/S

GMP standards implementation to all modern pharmaceutical manufacturers has been completed,

demonstrating that Taiwanese pharmaceutical manufacturing levels are now aligned to international

standards, giving it access to global markets. The history on the implementation of GMP is illustrated in

Figure 3-5.

3. Promoting Pharmaceutical Projects Professional Consultation

(1) Under the Executive Yuan's

Taiwan Biotech Industrialization Take-off Action Plan

, TFDA emphasized

the importance of professional consultation. A pharmaceutical consultation mechanism is built to

work with all the manufacturers in Taiwan.

(2) By complying with four indexes, Innovative, Contributive, Effective and Satisfactory stages as

screening criterion, TFDA expedites the process to support manufacturers to successfully complete

clinical trials until the final drug approval.

(3) In 2014, TFDA helped 33 projects to meet R&D milestones, which comprise 3 new drug approvals,

2 new drug applications, 7 phase III clinical trials, 11 phase II clinical trials, and 4 phase I clinical trials.

Furthermore, TFDA conducted more than 18 consulting meetings, offering customized advices suited

to their current product development and research status.


Consultation System

Overseas Registration

(Technology Development

Plan of 2014)

Pharmaceutical Project


(early harvest list)



Development Plan

Critical Path

Online Information

and Publications

Written Inquiries

and Consultation



Industry Communication

Platform (Priodic)

Figure 3-4

Professional Consultation System for Pharmaceutical Projects