14 Jul, 2022 European Commission proposes new rules on blood, tissues, and cells By Marco de Morpurgo Nicola Landolfi Today, the European Commission adopted a proposal for a new Regulation on standards of quality and safety for substances of human origin...
31 Jan, 2022 New EU Clinical Trial Regulation to take effect from today By Marco de Morpurgo Carlotta Busani Today, the new EU Clinical Trials Regulation (Regulation (EU) No 534/2014 – “CTR”) becomes applicable. The CTR introduces a unified...
07 Oct, 2021 New Clinical Trial Rules in the EU: A Practical Overview of the Upcoming Regulation By Marco de Morpurgo Carlotta Busani With the upcoming application of the new EU Clinical Trials Regulation (‘CTR’), the conduct of clinical trials in the European Union...
10 Sep, 2021 Clinical trials conducted pre-application can cause enabling disclosure By Richard Taylor Elinor Cavil In a recent webinar titled “Protecting Medical Devices in Europe – Avoiding Common Pitfalls”, Kieran Killough (Partner at HGF) pointed to...
07 Sep, 2021 New European Regulations on Medical Devices By Richard Taylor Elinor Cavil New EU regulations governing medical devices and in-vitro diagnostic devices were introduced in May 2017 - the Medical Devices Regulation...
01 Feb, 2021 Hungarian government legislative act opens the door to Chinese vaccines – the first to do so in the EU By Eszter Varga On Thursday evening (28 January 2021) a new Government Decree (Nr. 19/2021) was published in the Official Journal of Hungary amending the...