Categories:
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
Ler mais
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
Ler mais
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
Ler mais
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
Ler mais
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
Ler mais
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
Ler mais
ANVISA – Agency accepted in international inspection program
The Brazilian Regulatory Agency (Agência Nacional de Vigilância Sanitária – ANVISA) was accepte
Ler mais
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
Ler mais
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
Ler mais
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
Ler mais
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
Ler mais
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
Ler mais