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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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COFEPRIS – Recognition of Marketing Authorizations from Reference Authorities – updated 18th March
On January 28, 2020, an Agreement from the Mexican Comisión Federal para la Protección Contra Ries
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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 on
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EMA – Pilot programme for international cooperation in GMP inspection of manufacturers of sterile medicinal products for human use
The European Medicines Agency (EMA) and its European and international partners launched a pilot pro
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INFARMED – Economic Evaluation by INFARMED
With two publications on December 16, Infarmed informs the public about measures taken in support of
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ICH News
The International Harmonization Council (ICH) met in Singapore from 16 to 20 November 2019, bringing
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