1. The European
Medicines Agency. EMA reviewing
medicines containing valsartan from Zhejiang Huahai following detection
of an impurity: some valsartan medicines being recalled across the
EU. EMA/459276/2018, 2018.
2. U.S. Food
and Drug Administration. FDA
provides update on its ongoing investigation into ARB drug products;
reports on finding of a new nitrosamine impurity in certain lots of
losartan and product recall, 2019.
3. The Nitrosamine “Saga”: Lessons Learned from Five Years of Scrutiny
4. EMA. Questions and
answers for marketing
authorisation holders/applicants on the CHMP Opinion for the Article
5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities
in human medicinal products, 2023.
5. U.S.
Department
of Health and Human Services, Food and Drug Administration. Recommended Acceptable Intake Limits
for Nitrosamine Drug SubstanceRelated Impurities (NDSRIs) Guidance
for Industry, 2023.