European Regulatory Watch

Oct 02, 2018
Pharmaceutical Technology
A European task force outlines its upcoming efforts to combat drug shortages.
Sep 02, 2018
Pharmaceutical Technology
The European Commission’s proposed amendment on SPC waivers has sparked opposing views from drug originators and producers of generic drugs and biosimilars.
Aug 02, 2018
Pharmaceutical Technology
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.
Jul 02, 2018
Pharmaceutical Technology
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
Pharmaceutical Technology
The European Union is collaborating with the Pharmaceutical Inspection Co-operation Scheme to develop similar guides for evaluating inspectorates’ competency.
Apr 02, 2018
Pharmaceutical Technology
The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications.
Mar 02, 2018
Pharmaceutical Technology
The upcoming serialization deadline and the United Kingdom's departure from the European Union could result in supply bottlenecks.
Feb 02, 2018
Pharmaceutical Technology
Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.
Jan 02, 2018
Pharmaceutical Technology
The repercussions of EMA’s relocation and Brexit will continue to be the dominant regulatory issue throughout 2018.
Dec 02, 2017
Pharmaceutical Technology
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.
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