EMA Promises Regulatory Flexibility During the Pandemic

The EMA said it will allow firms struggling to meet quality requirements when they increase manufacturing capacity to meet demand during the COVID-19 pandemic to use a risk-based approach.

Companies may also postpone marketing authorization renewals if they are having trouble meeting their deadlines due to the pandemic, the agency said in a new guidance.

Manufacturers of essential medicines will also be allowed to quickly change suppliers or manufacturing sites under certain conditions. For example, they will be allowed to source starting materials, reagents, intermediates and active substances from suppliers not listed in their marketing authorizations.

The EMA is also allowing national marketing authorizations to be granted for in-demand drugs if they have already been authorized in another EU member state in order to allow newer member states to access them.

Read the full EMA guidance here: www.fdanews.com/04-13-20-Guidance.pdf. — James Miessler