Voltar 08 mai 2019
  • Novidades da 19ª semana (06 a 12 Maio) 0

EC - EUROPEAN COMISSION

SAFETY FEATURES FOR MEDICINAL PRODUCTS FOR HUMAN USE

Pharmaceuticals: Commission launches new version of the Union Register

Questions and Answers - Version 14

Withdrawal of the United Kingdom and EU rules for batch testing of medicinal products

 

 

ECA - EUROPEAN COMPLIANCE ACADEMY

MRA EU - FDA has approved two more countries

With the Mutual Recognition Agreement between Europe and the USA, inspections are to be mutually recognised in the future. The FDA's approval of the EU Member States proceeds successively. Two more countries have recently been approved.

 

Q&As on Safety Features - Version 14

The European Commission published version 14 of the Q&A´s on Safety features for medicinal products for human use.

 

Ensuring the data integrity of cloud service providers

The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 3: What agreements need to be included in contracts with cloud service providers in order to ensure data integrity?

 

 

EDQM

No new developments

 

 

EMA – EUROPEAN MEDICINES AGENCY

Working together for safe medicines in the EU

EMA launches a social media campaign to highlight how the European medicines regulatory network keeps medicines available in Europe safe and effective.

 

 

FDA

UPDATE - FDA alerts patients and health care professionals to Vivimed’s recall of losartan medication due to NMBA

FDA is alerting patients and health care professionals to a voluntary recall of 19 lots of losartan potassium tablets made by Vivimed Life Sciences Pvt Ltd in Alathur, Chennai, India and distributed by Heritage Pharmaceuticals Inc, East Brunswick, New Jersey.

 

FDA Updates and Press Announcements on Angiotensin II Receptor Blocker (ARB) Recalls (Valsartan, Losartan, and Irbesartan)

FDA posted laboratory test results showing NDEA levels in recalled valsartan products as well as an assessment of the cancer risk from NDEA in valsartan

 

 

GDP Association

No new developments

 

 

HMA

No new developments

 

 

HMA - CMDH

Q&A on how to handle eCTD for ASMF submissions

 

 

ICH

No new developments

 

 

INFARMED

Recolha voluntária de lote do medicamento Fibrocide, 25 mg, comprimido revestido

A Bene Farmacêutica, Lda. irá proceder à recolha voluntária do lote 202B152 com o prazo de validade 01/2020 do medicamento Fibrocide, polisulfato sódico de pentosano, 25 mg, comprimido revestido com o número de registo 8118331.

 

Recolha voluntária de lotes do medicamento Cianocobalamina Labesfal, 1 mg/1 ml, solução injetável

A empresa Labesfal - Laboratórios Almiro, S.A. irá proceder à recolha voluntária dos seguintes lotes do medicamento Cianocobalamina Labesfal, cianocobalamina, 1 mg/1 ml, solução injetável, com o número de registo 5126891, por terem sido detetados valores fora de especificação para o ensaio de doseamento e de compostos relacionados.

 

Infarmed publica estudo sobre anti-histamínicos

O estudo agora publicado revela que a utilização de anti-histamínicos aumentou durante todo o período de análise apresentado. Apesar de se observar um ligeiro decréscimo em 2017, em 2018 voltou a aumentar, atingindo 6,3 milhões de embalagens.

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