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AI in drug development: what changes in Europe and the US?
EMA and FDA have set out ten common principles for the use of artificial intelligence in drug develo
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ANVISA Presents eCTD 4.0 Strategy with Structured Data in the IDMP Standard to the Pharmaceutical Industry Sector
Vita, represented by consultant Alessandra Rolim, attended the online meeting held on October 15, 20
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MHRA Withdraws Marketing Authorization of IXCHIQ Vaccine Following Safety Review
On October 20, 2026, the UK regulatory agency (MHRA) announced, in its Drug Safety Update, the withd
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ANVISA presents PONTE Project, a Pilot for Technical Interaction During the Quality Assessment of Medicinal Products
On July 23, 2026, ANVISA’s Medicinal Product Quality Assessment Unit (GQMED/GGMED) presented t
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ANVISA Publishes Q&A on the New Herbal Medicines Framework and Clarifies the Adaptation of Authorized Products
On October 13, 2026, ANVISA released the Questions and Answers (Q&A) document on the new rules f
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ANVISA amends resolutions for BA/BE and Biowaiver criteria removing the requirement for Vasoconstrictor (Skin Blanching) studies for Semisolid Topical Corticosteroids
On October 5, 2026, ANVISA published in the Federal Official Gazette (DOU) Resolution RDC No. 1,044
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EAMI Network Turns 30 with a Focus on Regulatory Convergence and Reliance
From September 21 to 24, Lisbon welcomed the 15th Meeting of the Network of Medicines Authorities of
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ANVISA Proposes a Pathway to Reclassify Synthetic Analogs of Biological Products as Similar (Branded Generic) Medicinal Products
On October 5, 2026, ANVISA’s General Management of Medicines (GGMED) signed Technical Note (NT
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Strategic API Mapping: Why It Matters for Brazil’s Pharmaceutical Supply Chain – updated on 10/29/2026
Launched in April 2026 and scheduled to run for one year, the “Strategic APIs for Brazil Project:
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Sindusfarma and RAPS Brazil: The Future of the Regulatory Affairs Professional
The event on the future of the Regulatory Affairs professional, organized by Sindusfarma and RAPS Br
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Infarmed, Portugal’s Health Authority, Cements Its Leading Role in European Regulation
The role Infarmed plays within the European regulatory network was highlighted by the EMA during an
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Brazil’s Pharmaceutical Market Reached R$182.8 Billion in 2025, According to CMED’s Annual Report
The Executive Secretariat of the Medicinal Product Market Regulation Chamber (CMED) has published th
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