OR WAIT null SECS
March 02, 2017
Efforts to harmonize the fragmented regulatory framework for pharmaceuticals in the European Union continue to be a challenge.
February 02, 2017
Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.
January 01, 2017
How involved should HTA bodies be in assessing cost effectiveness and reimbursements?
December 02, 2016
Better co-ordination within and between regions is needed to improve the global regulation of medicines, according to the European Medicines Agency.
November 02, 2016
Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures.
October 02, 2016
Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems, particularly those stemming from post-authorization changes in the manufacturing process.
September 12, 2016
The new regulations aim to introduce greater consistency and uniformity in the assessment and approval of medical devices and in-vitro diagnostics across the European Union.
August 01, 2016
The pharmaceutical industry now braces itself for the consequences and complexities that could follow in the wake of the United Kingdom’s decision to leave the European Union.
July 02, 2016
The impact of pharmaceutical manufacturing on the environment has triggered demands for tighter environmental controls in EU and national legislations.
June 01, 2016
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.