Coronavirus (COVID-19)—European guidance released for authorised medicines

Article summary

The European Commission, the European Medicines Agency and the European medicines regulatory network have jointly released new guidance on adaptations to the regulatory framework during the coronavirus (COVID-19) pandemic. Regulatory flexibilities have been applied in order to help pharmaceutical companies ‘cope with the consequences of the pandemic, while ensuring a high level of quality, safety, and efficacy for medicinal products made available to patients in the EU’. The guidance includes information regarding marketing authorisations, regulatory procedures, manufacturing and importation, quality requirements, and labelling and packaging requirements of medicinal products intended for use against coronavirus.