OR WAIT null SECS
October 02, 2018
A European task force outlines its upcoming efforts to combat drug shortages.
September 02, 2018
The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.
August 02, 2018
Publication of proposed new regulations for pharmaceuticals in the environment has been postponed due to challenges in working out solutions and establishing a common framework.
July 02, 2018
EMA, the leading driver behind GMP inspection collaboration schemes, will be cutting back its involvement because of the need to concentrate on its relocation to Amsterdam.
May 02, 2018
The European Union is collaborating with the Pharmaceutical Inspection Co-operation Scheme to develop similar guides for evaluating inspectorates’ competency.
April 02, 2018
The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications.
March 02, 2018
The upcoming serialization deadline and the United Kingdom's departure from the European Union could result in supply bottlenecks.
February 02, 2018
Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.
January 02, 2018
The repercussions of EMA’s relocation and Brexit will continue to be the dominant regulatory issue throughout 2018.
December 02, 2017
The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.