EC publishes report on orphan medicine regulation
The European Commission (EC) has published its evaluation of the regulations over 2000-2017 (medicines for rare diseases) and 2007-2017 (medicines … read more »
Industry bodies respond to Health Innovation Partnership Proposal
The European Commission is currently considering partnership schemes to take forward under the Horizon Europe programme, among which is the … read more »
EMA and FDA strengthen collaboration on medicines
The European Commission (EC), European Medicines Agency (EMA) and US Food and Drugs Administration (FDA) have agreed new priorities in … read more »
EU Commission to launch new Pharmaceutical Strategy
The EU has released a preliminary roadmap for the creation of a new pharmaceutical strategy, in order to ensure quality, … read more »
European Council delays application of the Medical Devices Regulation to prioritise COVID-19
The European Council has voted unanimously to delay the implementation of the Medical Devices Regulation (MDR) by one year and … read more »
European Commission issues guidance to maintain clinical trials during the COVID-19 pandemic
The European Commission (EC) has published simple and flexible guidance to prevent disruption of clinical research in Europe during the … read more »
EFPIA sounds warning on EU joint HTA
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published a statement expressing its concerns over the current proposal … read more »
Germany to benefit from EU-US mutual recognition agreement for GMP inspections
Germany has been added to the list of EU member states able to approve GMP compliance within the mutual GMP … read more »
Two additional countries to benefit from EU-US mutual recognition agreement for inspections
Luxembourg and the Netherlands have been included in the GMP mutual recognition agreement between the EU and the US. Both … read more »
EMA launches a social media campaign to highlight the European medicines regulatory network
The EMA has launched a social media campaign to highlight the way the European medicines regulatory network keeps medicines available … read more »
