States Signs MOU with Vietnam for Drug and Device Safety
The United States and Vietnam completed a memorandum of understanding (MOU) to improve the safety of drugs and medical devices that are shared between the two countries. The MOU will extend over a three year period, as described in a press release from the Food and Drug Administration.
The MOU is a result of ongoing discussions between officials from Vietnam and Health and Human Services Secretary Mike Leavitt. The effort commenced just a few months ago and is one step forward in the commitment to the safety of imports. Similar efforts are underway with governments in Central and South America.
Specifics of the agreement with the Vietnamese government include the following:
- Sharing of information on regulations and laws, as well as training and guidance for maintaining safety after product approval,
- Combined workshops detailing safety of medicinal products, and
- Training to support implementation of best practices within the conduct of clinical trials, including appropriate regulatory inspections.
This strategy to address import safety was implemented by the Interagency Working Group on Import Safety. The group intends to provide incentives to assure the safety of products both entering and leaving the United States.
July 9, 2008 Related topics: Partnerships & Consortia, Quality, Safety, Errors