ANVISA – Resolution RDC 753/2022 – Review to RDC 200/2017 – Marketing Authorization of New, Innovative, Generic and Similar Medicinal Products – updated on October 10th, 2022

On October 7, at Public Ordinary Meeting ANVISA 19/2020, it was approved the draft for Public Co

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ANVISA – Questions & Answers on RDC 359/2020, which instituted DIFA and CADIFA for API used in the manufacture of Drug Products

On September 28th, ANVISA published the document Questions & Answers on RDC 359/2020, whi

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ANVISA – Service Guidance on flows for analysis of drug product application

On September 23, ANVISA published Service Orientation (OS) 90/2020, from the General Management of M

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ANVISA – New Legislation in Pharmacovigilance

On July 29th, it was published on Brazilian Official Gazette (DOU) the RDC Nº 406/2020, regarding t

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ANVISA – New Public Consultations for Simplified Notification of Low-Risk Medicines

On June 3, two Public Consultations regarding the Simplified Notification of Low Risk Medicines were

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ANVISA – New Public Consultation to change the rules for drug product labeling

On June 3, three Public Consultations regarding the Labeling of medicines were published in the Offi

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ANVISA – New legislation for Analytical Laboratories – updated 7th July

On May 28, RDC 390/2020 was published in Brazilian Federal Register (D.O.U), which establishes rules

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ANVISA – New Proposal for changing Legislation RDC 73/16 (Post-authorization of medicines)

On May 20, ANVISA published the Public Consultation 812/2020, which proposes changes to RDC 73/16 re

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DIGEMID (Peru) – New measures to guarantee the availability of medicinal products to the population

On December 5, 2019, the Supreme Decree (SD) 026-2019-SA was published in the Official Gazette, whic

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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 of doc

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WHO publishes draft about health product traceability policies

The World Health Organization (WHO) has published a draft about health product traceability policies

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ANVISA – Compliance of similar medicines

Anvisa issues Service Orientation N°79/GGMED/DIRE2/ANVISA, of January 29, 2020 and one Information

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