Europe – Procedural guidance during COVID-19 pandemic

The COVID-19 pandemic is having a significant impact on European regulatory activity. Many pharmaceutical companies are being directly and indirectly affected by this global situation and had to modify their working procedures and/or regulatory activities to respond to the demands. Likewise, many Health Authorities are carrying out a prioritisation of activities in order to cover the needs that the current situation demands.

The European Commission, the European Medicines Agency and the Heads of Medicines Agencies network (ECEMA and HMA, respectively) have assessed the situation and agreed on a number of measures to facilitate the management of marketing authorisations for human medicinal products considered crucial during the pandemic period.

The objective of these measures agreed at European level is to promote regulatory flexibility, facilitate, simplify and accelerate the administrative procedures, as far as possible, in order to respond more efficiently to emerging needs during this period.

With this objective the European Commission, in collaboration with the network of Agencies, published questions and answers on regulatory expectations for medicinal products for human use during the COVID-19 pandemic…