European Regulatory Watch

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.
Nov 02, 2017
Pharmaceutical Technology
The shift toward continuous manufacturing among European pharmaceutical manufacturers has not been accompanied by a similar strong increase in the use of automation and sensor-based on-line monitoring.
Oct 02, 2017
Pharmaceutical Technology
The European Commission is striving to tackle environmental pollution by pharmaceuticals as a means of curbing antimicrobial resistance.
Sep 02, 2017
Pharmaceutical Technology
EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.
Aug 02, 2017
Pharmaceutical Technology
EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.
Jul 28, 2017
By Pharmaceutical Technology Editors
The agency is asking public consultation on the concept paper.
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