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Is Europe putting cancer research at risk?

25-07-2014

The European Society for Medical Oncology (ESMO) has expressed concern that the proposed European Union…

EuropeOncologyPharmaceuticalRegulationResearch

EMA delays formal adoption of publication of clinical trial data policy

EMA delays formal adoption of publication of clinical trial data policy

10-07-2014

The European Medicines Agency management board has postponed formal adoption of the policy on publication…

EuropeEuropean Medicines AgencyEuropean UnionPharmaceuticalRegulationResearch

EMA agrees policy on publication of clinical trial data with more user-friendly amendments

EMA agrees policy on publication of clinical trial data with more user-friendly amendments

13-06-2014

The European Medicines Agency management board agreed the policy on publication of clinical trial data,…

EuropePharmaceuticalRegulationResearch

EMA “look, but don’t touch” terms of use for clinical study data are impracticable, says IQWiG

EMA “look, but don’t touch” terms of use for clinical study data are impracticable, says IQWiG

28-05-2014

The German Institute for Quality and Efficiency in Health Care (IQWiG) has taken issue with plans announced…

EuropeGermanyPharmaceuticalRegulationResearch

Merck and Endocyte pull CMA for vintafolide and companion imaging component in EU

20-05-2014

US pharma giant Merck & Co and Endocyte have withdrawn their conditional marketing authorization applications…

EndocyteEuropeMerck & CoOncologyPharmaceuticalRegulationResearchvintafolide

EU Ombudsman concerned about change of policy at EMA on clinical trial data transparency

16-05-2014

In a letter to the European Medicines Agency, the European Ombudsman, Emily O'Reilly, has expressed concern…

EuropePharmaceuticalRegulationResearch

European Commission specifies post-authorization efficacy study guidelines

European Commission specifies post-authorization efficacy study guidelines

11-04-2014

The European Commission has adopted a delegated act specifying the situations where a post-authorization…

EuropeEuropean Medicines AgencyEuropean UnionPharmaceuticalPharmaceutical industryPharmaceutical sciencesPharmacologyRegulationResearch

EMA plans targeted discussions on clinical trial data policy

EMA plans targeted discussions on clinical trial data policy

09-04-2014

The European Medicines Agency will launch a final round of targeted consultations with key stakeholders…

EuropePharmaceuticalRegulationResearch

EFPIA calls for collaboration in the implementation of Clinical Trials Regulation

03-04-2014

The global market for clinical trials is becoming increasingly competitive and Europe runs the risk of…

EuropePharmaceuticalRegulationResearch

MEPs vote for more transparent and simpler European clinical trial rules

03-04-2014

Pharmaceutical companies and academic researchers will have to post the results of all their European…

EuropePharmaceuticalRegulationResearch

SMEs, academia significant originators of innovative medicines in the EU

SMEs, academia significant originators of innovative medicines in the EU

03-02-2014

More than 40% of innovative medicines recommended for marketing authorization in the European Union between…

EuropePharmaceuticalRegulationResearch

Agreement by the European institutions on the text of a new EU Clinical Trial Regulation

Agreement by the European institutions on the text of a new EU Clinical Trial Regulation

20-12-2013

After detailed negotiations, the Committee of Permanent Representatives (COREPER I) the Member States…

EuropePharmaceuticalRegulationResearch

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