As the biopharmaceutical industry globalizes, companies face the challenge of navigating regulatory submissions across multiple countries and regions to bring innovative therapies to patients worldwide. To streamline this complex process, several regulatory authorities have established collaborative initiatives that enable concurrent review of applications among participating members. Two such frameworks are Project Orbis and the ACCESS Consortium, which aim to expedite cross-jurisdictional approvals while upholding stringent standards for quality, safety, and efficacy.
Key takeaways
- Project Orbis enables concurrent submissions and reviews with the FDA and other participating regulatory authorities.
- The ACCESS Consortium's work-sharing initiative divides review responsibilities among members.
- Both initiatives reduce duplication of efforts and align regulatory interactions for faster approvals.
- Thorough planning is required to manage multi-jurisdictional filings and dynamic review processes.
- Robust project management and regulatory expertise are essential for successful execution.
To gain valuable insights into Project Orbis and the ACCESS Consortium work-sharing model, read the full article.
