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 »
EU Expert Group publishes report on tools and methodologies to assess the efficiency of healthcare services
The EU Expert Group on Health Systems Performance Assessment (HSPA) has published its report “Tools and methodologies to assess the … read more »
European Parliament passes market exclusivity legislation changes
The European Parliament has voted to pass reforms to laws around competition from generics and biosimilars. These changes would allow … read more »
