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ANVISA – Cadifa Panel Launches!
Anvisa has just launched two extremely useful panels for monitoring the process of Letter of Suitabi
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ANVISA – Publication of the regulation for admissibility of analysis carried out by a Foreign Regulatory Authority (Reliance) in Brazil
In August 2022, ANVISA published the Resolution – RDC No. 741, of August 10, 2022, which provides
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EMA – ICH opens public consultation for international harmonization of real-world evidence terminology
The European Medicines Agency has published for public consultation an ICH Reflection Paper on “Pr
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ANVISA – List of Active Substances for Periodic Benefit-Risk Evaluation Reports (updated on December 20th, 2021)
On December 13th, 2021, ANVISA published the list of Periodic Benefit-Risk Assessment Reports (RPBR)
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ANVISA – Deadline extension for the implementation of packaging process online control and 100% integrity test
After some deliberations between the regulated sector and the regulatory authority, on December 1st,
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ANVISA – Guideline on Remote Inspections
On November 25th, 2021, Anvisa published Guideline No. 54/2021 (version 1) on Remote Inspections. Du
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EDQM – Notification to CEP holders: Implementation of the European Pharmacopoeia Supplement 10.7
In October 2021, the EDQM (European Directorate for the Quality of Medicines and Healthcare) publish
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ANVISA – Publication of new regulation to expand clinical trials with medicinal products in Brazil
On November 3rd, 2021, ANVISA published the Resolution of the Collegiate Board of Directors –
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ANVISA – The addition to the application of origin should be submitted by electronic system – Sistema Solicita
In order to improve the link between applications for addition to their respective applications of o
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ICH – Review Procedures of ICH M7(R2) and ICH E8(R1) Guidelines Drafts Advance – updated 27th October, 2021
On October 6, 2021, the ICH published updates on the status of the issuance of the second revision o
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EMA – Concern on the safety of titanium dioxide could result in reformulation of drug products in Europe (updated on August 10, 2022)
Since 2020, titanium dioxide (TiO2) has been the subject of concern about its safety for use as a fo
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ANVISA – Process Optimization for importing Cannabis-based products by individuals in Brazil – updated on November 29th
In October 2021, some important rules were published for the process of importing Cannabis-based pro
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