Consultations open for EC legislative proposals
The European Commission (EC) has launched three consultations on regulations in the area of health, all open until February 2021. … read more »
European Commission publishes pharmaceutical strategy
The European Commission has published its pharmaceutical strategy for the coming years. The principal aims of the pharmaceutical strategy are … read more »
MHRA publishes guidance on new assessment routes
The Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on new approaches to assessment that will be available … read more »
European Commission 2021 Work Programme released
The European Commission (EC) has presented its work programme for 2021, entitled A Union of vitality in a world of … read more »
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 »