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March 19, 2014
Looking to improve patient access to new medicines, EMA creates a pilot project to explore an adaptive licensing approach with real medicines in development.
March 06, 2014
Agencies extend successful pilot program to further harmonization of QbD topics.
March 02, 2014
Manufacturers are taking measures to comply with new package safety rules.
February 11, 2014
EMA releases an update on its flu vaccine guidance.
EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.
February 02, 2014
High technology assessments are having an impact on biosimilars development in Europe.
January 30, 2014
EMA's guidance focuses on the use of pharmacogenomics to improve drug safety monitoring.
November 26, 2013
European Medicines Agency announces the launch of the Accelerated development of vaccine benefit-risk collaboration in Europe (ADVANCE) project.
November 07, 2013
Includes a new approach on developing antibacterial agents targeted against multidrug-resistant (MDR) pathogens where patients have very limited or no remaining treatment options.
November 02, 2013
Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.