EU: EMA, Commission, and HMA issue guidance on clinical trials and Coronavirus
The European Medicines Agency ('EMA') announced, on 20 March 2020, that it had issued, jointly with the European Commission ('the Commission') and the Head of Medicines Agencies ('HMA'), guidance on the Management of Clinical Trials during the COVID-19 ('Coronavirus') pandemic ('the Guidance'). In particular, the Guidance provides concrete information on changes and protocol deviations which may be needed in the conduct of clinical trials to deal with extraordinary situations. In addition, the Guidance highlights that, where a trial participant is unable to attend the site, measures such as home nursing, if possible given social distancing needs, or contact via phone or telemedicine means, may be required to identify adverse events and ensure continuous medical care. However, the Guidance finds that requirements for data protection should be taken into account when implementing these measures.