Categories:
Whitepaper: Diffferences between CTD Brazil and UE: a look at CMC requirements
Our daily lives at Vita are full of discussions about technical and regulatory differences in the re
Ler mais
ANVISA – Public Consultation for Revision of RDC 47/2009, which establishes the rules for drug package leaflet
On December 2020, ANVISA published the Public Consultation for Revision of DRC Nº 47 of September 8
Ler mais
EMA publishes Questions and Answers document on Brexit
On January 1, 2021, the United Kingdom (UK) will be considered a “third country” with i
Ler mais
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
Ler mais
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
Ler mais
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
Ler mais
ANVISA – New Legislation in Pharmacovigilance
On July 29th, it was published on Brazilian Official Gazette (DOU) the RDC Nº 406/2020, regarding t
Ler mais
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
Ler mais
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
Ler mais
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
Ler mais
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
Ler mais
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
Ler mais