Regulatory Reliance Pathways: Challenges And Opportunities Ahead
International interest in fast-track regulatory reliance and collaboration pathways such as Project Orbis and the ACCESS Consortium has grown in recent years, a trend that looks set to continue in 2024. But some policy experts have warned that faster approvals are not always better, with one academic claiming the bar for marketing authorizations has dropped “far too low.”
You may also be interested in...
Companies wanting to use the new accelerated procedure will be paying more than £68,000 for the privilege, and will have to inform the UK medicines agency of any divergent decisions by reference regulators.
Pharmaceutical companies that develop new medicines for life-threatening or severely debilitating conditions could be eligible to file for a priority review in the five ACCESS Consortium member countries under a new pilot scheme.
Sixteen cancer therapies have been granted marketing authorizations or label variations in the US this year via the Project Orbis scheme. However, the majority of these are still under review by Orbis partners, which have also been outpaced by the non-Orbis EU.