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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 Questions
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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 Questions
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ANVISA – Agency accepted in international inspection program
The Brazilian Regulatory Agency (Agência Nacional de Vigilância Sanitária – ANVISA) was accepte
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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) published
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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 Question &am
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ICH – The ICH Q13 draft Guideline reaches Step 2 of the process
In July 2021, the International Council for Harmonisation of Technical Requirements for Pharmaceutic
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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 procedu
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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 publicat
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Whitepaper: Medicinal Cannabis Products – Regulatory differences between Brazilian and Mexican Legislations
We have published our new Whitepaper that describes the main differences between Mexican and Brazili
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ANVISA – Update of the Guideline 20/2019 on topical and transdermal products
ANVISA published the second version of Guideline 20/2019, which provides guidance on quality require
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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 version of
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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 the re
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