European Regulatory Watch

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.
Jul 02, 2017
Pharmaceutical Technology
Greater transparency and reliability of information are needed in the quality assessments of biosimilars.
Jun 02, 2017
Pharmaceutical Technology
The impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.
May 08, 2017
Pharmaceutical Technology
Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.
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