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European Medicines Agency

Showing 8 posts of 23 posts found.

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EMA launches project to boost early patient access to drugs

September 8, 2015
Research and Development EMA, European Medicines Agency, MAPPs, adaptive pathways, drug development, market access

The EMA is launching an adaptive pathway project to bring new medicinal products to market in Europe.  The ADAPT SMART …

News
Vaccination

EMA backs GSK’s malaria vaccine for use in Africa

July 24, 2015
Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing CHMP, Committee for Medicinal Products for Human USE, EMA, European Medicines Agency, GSK, WHO, malaria, world health organization

GSK has taken a significant step forward toward being the first company to bring a malaria vaccine to market, after …

News
EMA

EMA in push for more paediatric drug trials

July 24, 2015
Medical Communications, Research and Development EMA, European Medicines Agency, clinical trials, drug development, paediatrics

The European Medicines Agency has relaxed some of its rules around the development of drugs in children, in order to …

News
EM HQ

Big-name generics among new CHMP recommendations

April 27, 2015
Sales and Marketing CHMP, EMA, European Medicines Agency, Lyrica, pregabalin

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended 11 new medicines for approval, among them several …

News

EMA begins pilot for electronic drug applications

March 14, 2012
Medical Communications EMA, European Medicines Agency, eCTD

The European Medicines Agency has launched a pilot scheme that allows pharma firms to submit new drug applications electronically.  The …

News

EMA road map to prioritise pharmacovigilance

January 28, 2011
Research and Development, Sales and Marketing EMA, European Medicines Agency, pharmacovigilance

The European Medicines Agency is to prioritise issues such as pharmacovigilance over the next five years, while also looking closely …

News

EMA to widen public access to documents

December 1, 2010
Research and Development, Sales and Marketing EMA, European Medicines Agency, European Ombudsman, patient information, transparency

The European Medicines Agency has agreed to give greater access to documents on medicines for human and veterinary use, after …

News

Pharma engages HTA bodies in early-stage drug discussions

October 27, 2010
Research and Development, Sales and Marketing Andrew Witty, AstraZeneca, EMA, European Medicines Agency, GlaxoSmithKline, Johnson & Johnson, health technology assessment, hta

Three pharma companies are taking part in a new pilot to harmonise European standards in health technology assessment (HTA). AstraZeneca, …

News
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