The UK regulator wants to be a “catalyst for change” in reducing regulatory burdens, saying that better regulation based on science is in everyone’s interest.

Preparing for the assessment and post-approval monitoring of COVID-19 vaccines is taking up a lot of resources at the EMA, which has called on the European Commission to provide more support for such activities. The agency has also confirmed that no data have yet been submitted for its planned rolling reviews of potential vaccines.

The UK medicines regulator has a “unique opportunity” to evaluate the systems it operates and to “do things differently", according to its long-term interim head, June Raine.

The pharmaceutical industry has given a muted welcome to proposals for building up the EU's resilience to medicine shortages, saying many of the ideas will not tackle the root causes of supply problems and could even serve to undermine innovation. 

Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.

Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.