EMA consults on definition of starting materials for specific biological medicines
This article was originally published in SRA
Executive Summary
The European Medicines Agency has published a draft reflection paper to help manufacturers preparing marketing authorisation dossiers understand what would constitute a "starting material" in the case of specific groups of biological medicines1. The paper, which clarifies the definition of starting materials for such products, also addresses the extent to which any variability in the early manufacturing steps for the biologics would be acceptable.
You may also be interested in...
UK's MHRA Looks Beyond Brexit Transition Period
Now that the UK has left the EU, the UK’s medicines regulator says it will use the rest of this year to work out how best to ensure continuity of drug regulation after the Brexit transition period ends on 31 December.
UK MHRA Looks Beyond Brexit Transition
Now that the UK has left the EU, the UK’s medicines regulator says it will use the rest of this year to work out how best to ensure continuity of drug regulation after the Brexit transition period ends on 31 December.
Faster Approval Does Not Mean Faster Reimbursement
Securing accelerated assessment for a drug in any regulatory jurisdiction is a major boost for drug companies, but it does not necessarily translate into an earlier reimbursement decision.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: