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Nitrosamine Medicinal Products Contamination – Scenario in Europe, United States, and Latin America – updated on July 19, 2023
In 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in several [...]
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ANVISA – Traceability/Serialization
After ten years of extensive debate, since the enactment of Law 11.903 / 2009, on November [...]
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New Regulation for Stability Studies of Medicinal Products and APIs in Brazil – Resolution RDC 318/2019
On November 7, 2019, ANVISA published the Resolution RDC 318/2019, which defines the criteria [...]
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New Brazilian Regulatory Framework for API under Public Consultation
Approved by Anvisa’s Board of Directors, the Public Consultations of the New Regulatory [...]
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