EMA Modernizes Orphan Drug Process
The agency launched a secure online portal for orphan drug designation applications.
On June 19, 2018, the European Medicines Agency (EMA) announced the launch of “Iris”, a secure online portal for the submission of orphan drug designation applications. The new portal will allow applicants to submit and manage information and documents related to their application. The agency hopes the portal will reduce the time needed to prepare and submit applications.
Part of a long-term program to handle product-related applications and utilize master data in pharmaceutical regulatory processes, Iris allows applicants to check the status of their applications and receive automatic notifications of changes.
While the existing submission process will be available until Sept. 19, 2018, EMA is encouraging companies to start using the new portal. The agency has developed two new guidance documents with step-by-step instructions on how to use the new system.
Source: EMA
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
