The U.S and the EU are giving joint drug assessments a try. At the core of the three-year pilot: Quality by Design.
The FDA/EMA program will allow parallel evaluation of QbD components in select applications submitted to both agencies at the same time. The pilot, covering only chemical entities, will begin April 1.
The program will cover chemistry, manufacturing and control meeting requests as well as new drug applications and supplemental NDAs. Manufacturer participation is voluntary and the regulators ask for three months' notice before filing.
"Taking into account the global perspective of pharmaceutical manufacturing, and to facilitate the harmonized implementation of the International Conference on Harmonization concepts, the EMA and FDA agreed that experts from both agencies should exchange their views using real applications," the regulators say in a statement.
Pharma QbD uses a science-based approach to drug manufacturing and development as a means of ensuring product quality.
- here's the FDA announcement