European Regulatory Watch

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.
Apr 03, 2017
Pharmaceutical Technology
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.
Mar 02, 2017
Pharmaceutical Technology Europe
Efforts to harmonize the fragmented regulatory framework for pharmaceuticals in the European Union continue to be a challenge.
Feb 02, 2017
Pharmaceutical Technology
Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.
Jan 01, 2017
How involved should HTA bodies be in assessing cost effectiveness and reimbursements?
Dec 02, 2016
Pharmaceutical Technology
Better co-ordination within and between regions is needed to improve the global regulation of medicines, according to the European Medicines Agency.
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