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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 [...]
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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) [...]
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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 [...]
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EMA – Update of Pre-authorisation guidance for users of the centralised procedure
In July and September, the authority EMA (European Medicines Agency) updated the document [...]
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EMA – Update of Pre-authorisation guidance for users of the centralised procedure
In July and September, the authority EMA (European Medicines Agency) updated the document [...]
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EDQM – Notification to CEP holders: Implementation of the European Pharmacopoeia Supplement 10.6
In July 2021, the EDQM (European Directorate for the Quality of Medicines and Healthcare) [...]
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EMA – Update of the Document Regulatory Q&A on Herbal Medicinal Products
In August 2021, the European Medicines Agency-EMA published an update of the regulatory [...]
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EMA – Update of the Guideline on post-authorisation procedural advice for users of the centralised procedure
In July, the European Medicines Agency (EMA) has updated its Guideline on post-authorisation [...]
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Whitepaper – Differences between CADIFA (Letter of Suitability of the Active Pharmaceutical Ingredient) – ANVISA and CEP (Certificate of Suitability) – EDQM
In April 2021, the New Regulatory Framework for APIs in Brazil completed one year since its [...]
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EMA – Review of the Question and Answer Documents for Centralized Procedure
On February 2021, the European Medicines Agency (EMA) published on its website an updated [...]
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Whitepaper: Diffferences between CTD Brazil and UE: a look at CMC requirements
Our daily lives at Vita are full of discussions about technical and regulatory differences in [...]
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EMA publishes Questions and Answers document on Brexit
On January 1, 2021, the United Kingdom (UK) will be considered a “third country” [...]
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