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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 [...]
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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 [...]
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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) [...]
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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 [...]
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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. [...]
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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 [...]
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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 [...]
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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 [...]
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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 [...]
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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 [...]
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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 [...]
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50 years of Law No. 6,360/1976
This year marks 50 years since Law No. 6,360/1976 was enacted, the law that first established [...]
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