Page 62 - 2019食藥署年報(英文版)

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TFDA promptly and successfully verified the non-compliant pharmaceutical products

through rapid response and teamwork:

1. TFDA found that other active pharmaceutical ingredients of Valsartan also contained
NDMA and published recommended testing methods we developed to OMCLs
network, shared relative information to EDQM and MFDS to jointly maintain
medication safety with other administrative agencies worldwide. TFDA also required
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pharmaceutical ingredient of sartan drugs without NDMA and NDEA residues before
used in manufacturing process and incorporates the strategy into the GMP audit

focus to maintain medication safety.
2. TFDA successfully blocked two batches, totally 518,405 vials of noncompliant
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to OMCLs and GEON, actively demonstrate our determination to secure the quality
and safety of vaccines. In addition, TFDA also strengthened risk control mechanisms
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medication safety.

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