European and US agencies will cooperate to ensure ethical conduct of trialsBMJ 2009; 339 doi: https://doi.org/10.1136/bmj.b3274 (Published 10 August 2009) Cite this as: BMJ 2009;339:b3274
- Janice Hopkins Tanne
- 1New York
The US Food and Drug Administration and the European Medicines Agency (EMEA) have announced that they will work together to ensure that clinical trials “related to drug marketing applications” in the United States and Europe are conducted “uniformly, appropriately, and ethically.”
The “good clinical practices initiative” is expected to strengthen safeguards for participants in clinical studies as research becomes increasingly globalised.
In a joint statement the EMEA and the FDA said that in most cases the same clinical trials are used to support applications to both agencies for approvals of new drugs. Many of the …