The FDA and the EMA have established a new pilot program to assess quality by design (QbD) aspects of new drug applications (NDAs) and marketing authorization applications (MAAs). The program is voluntary. Each agency will separately assess QbD elements but the agencies will then communicate on their findings. This voluntary program will only apply to new chemical entities (NCEs) and not to biologics. The pilot wil run through March 2014.
The goal of the program is to increase the harmonization between the two agencies in their assessments of new applications relative to QbD elements -- specifically looking at the CMC section. The program originated of a concern that the ICH guidelines were not being interpreted the same from the two agencies. The pilot hopes to address by:
- Ensuring consistent implementation of ICH guidelines for manufacturing
- Increase awareness by staff who review marketing applications and inspect facilities
- Better define reviewer and inspector interaction
- Create mechanism for EMA/FDA reviewers to share findings
- Harmonize regulatory decisions to the greatest extent possible
"To fully implement QbD, we need to further harmonize the implementation of the guidelines, work collaboratively, and provide scientific, risk-based regulatory decisions in a timely manner, " said Janet Woodcock, director of FDA's CDER. See Benzinga.com.
Posted by Bruce Lehr March 20th 2011.