European medicines agencies launch public consultation on joint strategy The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have developed a joint strategy for the next five years. It was recently released for a two-month public consultation period (6 July, 2020). It outlines six priority areas: the availability and accessibility of medicines; data analytics, digital tools and digital transformation; innovation; antimicrobial resistance and
EU Clinical Trials Information System set to go live end of 2021 The EU’s Clinical Trials Information System (CTIS), a centralized portal and database for information storage foreseen by the Clinical Trials Regulation (2014), is set to go live in December 2021. The go live date was confirmed at the most recent virtual meeting of the Board of the European Medicines Agency (EMA) (11 June, 2020). In
FDA launches pioneering pilot to make public patient reported outcomes of clinical trials This week (23 June, 2020) the US Food and Drug Administration (FDA) launched a pioneering pilot project Patient Voice. It is an open source web portal that will for the first time make publicly accessible the information about patient-reported symptoms during cancer clinical trials. The project was initiated by the Oncology Center of Excellence to
