U.S., Vietnam Ink MOU on Device, Drug Safety

The U.S. and Vietnam have signed a three-year, renewable memorandum of understanding (MOU) to enhance the safety of medical devices and drugs traded between the two nations.

The MOU is the culmination of discussions between HHS Secretary Mike Leavitt and senior Vietnamese officials that began a few months ago as part of the new import-safety strategy created last November by a U.S. Cabinet-level Interagency Working Group on Import Safety.

The agreement with the Vietnamese specifically calls for cooperation in the following areas:

• Information sharing — the governments will exchange information on laws and regulations, guidance documents and training for postmarket safety surveillance of products;
• Workshops and training — the governments will conduct workshops on training that concerns medicinal products; and
• Best practices in clinical trials — HHS and the FDA will cooperate with Vietnamese officials on training in good clinical practice and the regulatory inspection of clinical trials.

The working group’s proposals included creating incentives to ensure that foreign manufacturers exporting products into the U.S. meet agency standards and allowing the destruction of medical products refused admission into the country to prevent their re-importation. Expedited destruction would apply to refused products that are valued below a given threshold or pose a certain level of risk to humans or animals.

In other efforts to strengthen the safety of health products, Leavitt was in El Salvador recently to participate in a forum with government officials and business leaders from Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua and Panama.