Voltar 10 jul 2019
  • Novidades 04 de Julho de 2019 0

EC - EUROPEAN COMISSION

Summary record - 11th Meeting of the STAMP Expert Group

 

Clinical trials: Call for all sponsors to publish results in EU database

In a joint letter published today, the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) reminded all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database.

 

Germany becomes the 27th Member State to benefit from the EU-US mutual recognition agreement for inspections

The mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories has made further progress.

 

ECA - EUROPEAN COMPLIANCE ACADEMY

New Warning Letters - Quality Units in the Focus

"Your firm's quality systems are inadequate". A sentence in a Warning Letter you would not like to read. Some companies now had to.

 

Creams, Gels & Pastes redefined

A revised version of the Ph. Eur. Monograph Semi-solid preparations for cutaneous application has been published in Pharmeuropa.

 

Serialisation: New Guidance for EU Inspectors

The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the safety features regulation.

 

EDQM

 Ph. Eur. Commission consults stakeholders on the general chapter on Multivariate Statistical Process Control (MSPC) (5.28)

The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on the new chapter 5.28 on Multivariate Statistical Process Control. The Ph. Eur. is the first pharmacopoeia to elaborate such a chapter.

 

 

EMA - EUROPEAN MEDICINES AGENCY

Medicine shortages: EU network takes steps to improve reporting and communication

The European Union task force set up to address problems with medicines supply has published two documents today

 

FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk with significant violations of manufacturing quality standards

The U.S. Food and Drug Administration has issued warning letters to three repackers of active pharmaceutical ingredients (API), B&B Pharmaceuticals, Inc., Asclemed USA, Inc., doing business as Enovachem and Spectrum Laboratory Products, Inc., for significant violations of current good manufacturing practice (CGMP) requirements.

 

 

FDA

(No new developments)

 

 

GDP ASSOCIATION

(No new developments)

 

 

HMA

Added in 3 July 2019

NEW - Report from the meeting held on 25-27 June 2019 

 

 

HMA - CMDH

(No new developments)

 

 

ICH

(No new developments)

  

 

INFARMED

Acesso a medicamentos contendo Cloreto de Potássio

 

Acesso a medicamentos contendo colestiramina

 

Pneumorel e Pneumorel retard - Revogação da AIM

O Grupo de Coordenação (CMDh) determinou a revogação das Autorizações de Introdução no Mercado (AIM) dos medicamentos para uso humano que contêm a substância ativa fenspirida, na sequência do parecer do Comité de Avaliação do Risco em Farmacovigilância (PRAC) da Agência Europeia de Medicamentos (EMA).

 

Lisados Bacterianos - Restrições da utilização

A Agência Europeia do Medicamento (EMA) recomenda que os medicamentos contendo lisados bacterianos sejam utilizados apenas na prevenção de infeções respiratórias recorrentes, com exceção da pneumonia.

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