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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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Update in Drug Regulation in China – Revocation of GMPc Requirements
On August 26, 2019, the Standing Committee of the National People’s Congress of China passed the A
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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 bloo
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ANVISA – Traceability/Serialization
After ten years of extensive debate, since the enactment of Law 11.903 / 2009, on November 13th, RDC
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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 for co
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