OR WAIT null SECS
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.
November 02, 2017
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.
October 02, 2017
The European Commission is striving to tackle environmental pollution by pharmaceuticals as a means of curbing antimicrobial resistance.
September 02, 2017
EMA recognizes that a regulatory framework, under which medicines and diagnostics are developed and approved independently, may not be ideal.
August 02, 2017
EMA recognizes the need to provide more assistance and guidance to SMEs developing new medicines and applying for marketing authorizations.
July 28, 2017
The agency is asking public consultation on the concept paper.
July 02, 2017
Greater transparency and reliability of information are needed in the quality assessments of biosimilars.
June 02, 2017
The impact of Brexit on the European drug approval regulatory framework presents challenges for EMA.
May 08, 2017
Many pharmaceutical companies are sceptical about IDMP despite the business benefits and its contribution to patient safety.
April 03, 2017
Both the European Union and United States are still ironing out issues such as confidentiality of information and recognition of competence of each party’s regulatory authorities in their agreement on GMP inspections.