Page 60 - 2019食藥署年報(英文版)

suggestions for different topics, so that the mentioned activities could be more comprehensive.
Furthermore, we also conducted research on RCEP national drug management, new drug R &
D regulations and policies, analyzed and wrote drug review procedures, health care business
policies, and international new drug regulations in various countries. A total of 4 research
reports were produced, which assisted competent authorities to stipulate strategies and promote
the implementation of policies to promote the global development of Taiwan’s biotechnology and
pharmaceutical industry.

4FDUJPO *NQSPWFNFOU PG %SVH 2VBMJUZ *OTQFDUJPO 5FDIOPMPHZFDUJPO
4

0SJHJO PG 1PMJDZJHJO PG 1PMJDZ
0S
Drugs must pass rigorous clinical testing for the verification of its efficacy and safety
EHIRUH HQWHULQJ LQWR PDUNHW +RZHYHU 7)'$ DFWLYHO\ LPSOHPHQWV VFLHQWL¿F SURRIV WR PRQLWRU
products with high risk, in order to reduce unpredictable risks after entering into market and

ensure the quality of drugs. We also enhance our inspection capabilities through the feedbacks
from the notification system, manage product warnings and cooperate with international
organizations.

* *NQMFNFOUBUJPO .FBTVSFTNQMFNFOUBUJPO .FBTVSFT

&TUBCMJTI B UFTUJOH NFUIPE GPS TBSUBO ESVHT UIBU NBZ DPOUBJO OJUSPTBNJOF
JNQVSJUJFT

The sartan drugs may contain nitrosamine impurities was continuously issued because of
a pharmaceutical ingredient called Valsartan may contain N-Nitrosodimethylamine (NDMA)

since the end of June, 2018.
TFDA actively started to develop a method for detecting NDMA by liquid chromatography
tandem mass spectrometer (LC-MS/MS, Figure 3-10) and applied the method to other active
pharmaceutical ingredient of Valsartan and found some of them also contain NDMA. In
addition, TFDA also enlarged testing scope to other sartan drugs, including Candesartan,
Irbesartan, Losartan, Olmesartan, Telmisartan, and Azilsartan. In response to the U.S. FDA's
safety alert, TFDA simultaneously brought "N-Nitrosodiethylamine (NDEA)" and "N-nitroso-

N-methyl-4-aminobutyric acid, (NMBA)" into our detecting targets. TFDA has announced the
testing methods for 3 nitrosamine impurities in active pharmaceutical ingredient of sartan drugs.

58