EMA statement clarifies Brexit situation
The European Medicines Agency (EMA) has released a statement to mark the start of the transition period between the UK … read more »
Medicines shortages: EU supply chain stakeholders issue paper calling for dialogue
Seven European institutions from across the cycle of medicines’ supply chain have called for dialogue “addressing the root causes of … read more »
No-Deal Brexit: Government announces minimum 6 month healthcare coverage for UK nationals living in the EU
The UK Government has confirmed that if the UK leaves the EU without a deal on 31st October 2019, it … read more »
EU and US complete GMP harmonisation process
The FDA and EMA have completed implementation of their mutual recognition agreement for GMP inspection, with Slovakia being recognised by … read more »
Guidance released for reporting and communication of medicine shortages in the EU
The EMA and HMA have released a set of guidance for marketing authorisation holders and others to help them report … read more »
EFPIA responds to EMA consultation on Regulatory Science Strategy
EFPIA has released its response to an EMA consultation, calling for support for innovation in clinical trials, improvement in regulatory … 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 »
Highlights from June EMA Management Board meeting
The EMA’s Management Board met on 12-13 June and discussed activities suspended during the Agency’s relocation to Amsterdam and its … 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 »
BIA chief executive reasserts harm to UK life sciences of no-deal Brexit
Steve Bates, chief executive of BIA, told the Exiting the EU Committee there are short- and long-term negative impacts of … read more »
