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ANVISA – Solicita System allows the addition of documents by third-party companies
ANVISA informs that the Solicita System now allows third parties companies to make amendments [...]
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ANVISA – Compliance of similar medicines
Anvisa issues Service Orientation N°79/GGMED/DIRE2/ANVISA, of January 29, 2020 and one [...]
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ANVISA – Proposal for new Bioavailability/ Bioequivalence (BA/BE) Studies
On January 2, 2020 ANVISA published in the Brazil the Public Consultation Nº 760 which provides [...]
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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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