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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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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ANVISA – Public Consultation for Revision of RDC 47/2009, which establishes the rules for drug package leaflet

On December 2020, ANVISA published the Public Consultation for Revision of DRC Nº 47 of September 8

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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” with i

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