OR WAIT null SECS
October 10, 2014
Iclusig?s original indication will remain unchanged after a thorough examination of its safety information by EMA.
October 02, 2014
Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines.
September 02, 2014
As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.
August 01, 2014
The European Union has developed a system for evaluating, approving and monitoring the safety of medicines that has also encouraged innovation.
June 02, 2014
Concern by environmentalists, regulators and manufacturers rises over the environmental impact of pharmaceuticals.
May 02, 2014
The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.
April 02, 2014
As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.
March 02, 2014
Manufacturers are taking measures to comply with new package safety rules.
February 02, 2014
High technology assessments are having an impact on biosimilars development in Europe.
January 02, 2014
With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.