Page 54 - 2020Taiwan Food and Drug Administration Annual Report

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Introduction of the Policy
Introduction of the Polic y

In view of the drug incidents containing nitrosamine impurities such as the
N-Nitrosodimethylamine (NDMA) happening around the world, TFDA has collected
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by initially checking; in addition, referring to international rules/regulations, the nitrosamine
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risk products by TFDA, and through the alerts and reporting system as well as international
cooperation to control the notification and ensure to enhance our capacity and capability of

inspection.

Implementation Strategy
Implementation Strate gy

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TFDA requires all of the active pharmaceutical ingredients such as Sartans, Ranitidine
and Metformin to be comprehensively tested batch-by-batch for the content of nitrosamine
impurities; TFDA also conducts risk assessment at the same time and requests to include the
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NDMA and N 1LWURVRGLHWK\ODPLQH 1'($ IRU WKH LQVSHFWLRQ VSHFL¿FDWLRQV RI 6DUWDQV LQ WKH
supplemental articles for the eighth edition of the Chinese Pharmacopoeia (3).

II. Evaluation of 44 drugs for possible residue of nitrosamine impurities
TFDA initially screened 44 high-risk drugs that may produce or contain NDMA according

to the international journals and research papers. With reference to the dosage of national health
insurance, long-term usage, dosage and intake types, etc., TFDA required the manufacturers on
November 13, 2019 to prioritize the evaluation and testing for the risk of nitrosamine impurities
that may be generated in the manufacturing process. For the active pharmaceutical ingredients
possessing the risk of residue of nitrosamine impurities, they shall be tested for the residue with
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III. Self-assessment on other drugs that shall not contain nitrosamine
impurities
TFDA initially prioritized them to include NDMA and NDEA for the inspection
specifications of Sartans in the supplemental articles for the eighth edition of the Chinese

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