Industry Picks Holes In Australia’s Plans To Use Overseas Assessments
Executive Summary
Industry believes that Australian proposals for speeding up drug registrations by using assessment reports from, or sharing work with, overseas regulators need a lot of fixes.
You may also be interested in...
Australia Publishes Plans For Global Regulatory Capacity Building
Australia has outlined its plans for building up regulatory capacity and work-sharing among medicines agencies at the regional and global level in the next financial year.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Moment Of Truth For Seven EU Filings; Cytokinetics To Make Its Case For Heart Failure Drug
The CHMP, the European Medicines Agency’s human medicines committee, will this week decide whether a range of new medicines merit being approved.