Voltar 03 dez 2019
  • Novidades 29 de Novembro de 2019 0

EC - EUROPEAN COMISSION

 

 Falsified Medicines: Aide-Memoire for Good Distribution Practices (GDP) inspections

 

 

ECA - EUROPEAN COMPLIANCE ACADEMY

 

Clinical Trials Regulation Questions & Answers Version 2.2

The European Commission (EC) published an updated Version 2.2 of the Questions & Answers relating to the Clinical Trials Regulation.

 

 

FDA Warning Letter for receiving potentially unsafe drugs

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving potentially unsafe drugs from Chinese suppliers.

 

 

Falsified Medicines: New EU Aide Memoire for GDP

The European Commission has published an aide memoire for Good Distribution Practices (GDP) inspection of wholesalers’ compliance with Commission Delegated Regulation (EU) 2016/161 for safety features.

 

 

Cannabis Monograph in the Swiss Pharmacopoeia

 

 

New Warning Letter - Quality Oversight in the Focus

Production and laboratory processes are for sure still a hot topic in inspections. But investigators are also focusing on the role of the Quality Unit and Quality Oversight.

 

 

Nitrosamines in Elastomers?

An USP Stimuli article on Elastomeric Components for Inhalation Packaging / Delivery Systems has been published in Pharmacopeial Forum, proposing to test for nitrosamines in elastomeric components used for inhalation products.

 

 

 

EDQM

 

(No new developments)

 

 

 

EMA - EUROPEAN MEDICINES AGENCY

(No new developments)

 

 

 

FDA

FDA alerts patients and health care professionals to two repackagers’ voluntary recalls of ranitidine

 

 

FDA warns Mylan for CGMP deviations

 

 

 

GDP ASSOCIATION

 

FDA Warning Letter for receiving potentially unsafe drugs

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving potentially unsafe drugs from Chinese suppliers.

 

 

 

HMA

(No new developments)

 

 

 

HMA - CMDH

 

 

UPDATE - Questions and answers on “Information on nitrosamines for marketing authorisation holders”

 

 

NEW - CMDh Best Practice Guide on Multilingual Packaging;

 

 

UPDATE - List of active substances for which data has been submitted in accordance with Article 45 of the Paediatric Regulation;

 

 

UPDATE - CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines;

 

 

UPDATE - Questions and Answers on generic applications;

 

 

UPDATE - Template - RMS End of Renewal Procedure

 

 

 

ICH

 

(No new developments)

 

 

 

 

INFARMED

 

Pesquisa de circulares no site do Infarmed mais fácil e intuitiva

A nova ferramenta de busca concentra a sua ação apenas nos documentos desta categoria - alertas de segurança, alertas de qualidade, circulares informativas em geral ou circulares normativas – e oferece, adicionalmente, possibilidade de filtrar os resultados por tipo de “produto” (medicamentos de uso humano, dispositivos médicos ou cosméticos).

 

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