US/Vietnam sign drug safety pact

The USA and the Socialist Republic of Vietnam have signed a memorandum of understanding to enhance the safety of drugs and medical devices, as well as food and feed, traded between the two nations.

The plan is the product of discussions between US Secretary of Health and Human Services Michael Leavitt and senior Vietnamese officials in Hanoi two months ago and exemplifies the new import safety strategy adopted by the US government in November 2007. Historically, US authorities have primarily relied on intervention at the border to intercept unsafe goods. The new strategy, crafted by a Cabinet-level inter-agency Working Group on Import Safety chaired by Secretary Leavitt, calls for actively working with trading partners to help ensure they build quality into every step of a product's life cycle.

Among others, the MOU calls for cooperation in areas such as: information-sharing by the two governments on their respective regulatory systems, such as details on laws and regulations; guidance documents; lists of drugs approved by the US Food and Drug Administration; and best practices in clinical trials - the HHS/FDA and its counterpart agencies intend to cooperate on training and inspections of clinical trials for the development of medical products.