EMA

EFPIA responds to EMA draft policy on access to clinical trial data

Wednesday, September 11, 2013 01:20 PM

EFPIA, representing the research-based pharmaceutical industry in Europe with a membership of 33 national associations and 40 pharmaceutical companies, has concerns about the EMA draft policy (0070) on publication and access to clinical trial data, saying it carries negative implications for public health in its failure to adequately protect the interests of patients and the research from which they benefit.

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EMA now accepting Safe-BioPharma digital signatures on eSubmissions

Friday, September 6, 2013 02:53 PM

Beginning this month, SAFE-BioPharma digital signatures will be accepted by the European Medicines Agency (EMA).  

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FDA, EMA approve C-Path’s simulation tool for Alzheimer’s trials

Friday, July 12, 2013 02:16 PM

Both the FDA and the EMA have independently reached favorable decisions on the value of independent nonprofit Critical Path Institute’s (C-Path) new disease simulation tool for improving trial design in mild and moderate Alzheimer’s disease (AD).

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EMA: Small, medium enterprises see consistent improvement in drug approvals

Friday, March 1, 2013 02:39 PM

Micro, small and medium-sized enterprises (SMEs) registered with the SME office of the European Medicines Agency have seen a consistent improvement in the success rate of their marketing-authorization applications (MAAs) over the past seven years, according to the SME offices’s 2012 annual report.

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European Medicines Agency to focus on efficiency, transparency in 2013

Thursday, January 10, 2013 02:21 PM

The European Medicines Agency’s management board has adopted the agency’s work program and budget for 2013, with priorities continuing to be ensuring assessment activities are conducted to the highest scientific levels, increasing efficiency in its activities and developing initiatives for greater transparency and communication with stakeholders.

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Researchers look to disease-modifying therapy to ward off, possibly prevent Alzheimer’s disease

Monday, December 19, 2011 10:25 AM

Just as statins help lower high cholesterol levels to reduce the risk of heart attacks, researchers are seeking a comparable approach for people with large amounts of beta amyloid, an abnormal protein in the brain commonly found in Alzheimer’s disease patients. Medicines would clear those proteins before any signs of memory loss or other early symptoms of Alzheimer’s appear. 

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Report: Clinical trials approved in Russia on course in third quarter

Monday, November 7, 2011 11:26 AM

The number of new studies approved in Russia during the third quarter of 2011 reached last year’s level, with the Ministry of Health and Social Development of the Russian Federation (MoH) approving 132 new clinical trials of all types, including local and bioequivalence studies, according to Synergy Research Group (SynRG), a Russia-based CRO. That’s only two trials below the number approved in the year-ago quarter.

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EU Clinical Trials Register to be available on WHO’s ICTRP portal

Thursday, September 22, 2011 02:13 PM

The European Union Clinical Trials Register (EU-CTR) has been recognized as one of the primary registries for the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP), according to PharmaTimes.

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START expands with phase I center in Shanghai

Thursday, September 22, 2011 10:45 AM

South Texas Accelerated Research Therapeutics (START), a US-based group that claims to run the world’s largest co-ordinated network of phase I clinical trials in oncology, has opened a phase I research facility in China at Fudan University Shanghai Cancer Centre, the city’s largest cancer hospital, according to PharmaTimes.

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EMA joins FDA in growing movement toward risk-based monitoring of clinical trials

Monday, September 19, 2011 08:02 AM

Along with the FDA and the Clinical Trials Transformation Initiative (CTTI), the European Medicines Agency (EMA) is advocating for risk-based monitoring of trials, while at the same time saying current GCP rules render quality management in trials too costly and need to be reworked.

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