US and Vietnam Join Hands for Drug Safety

July 9, 2008
BioPharm International Editors

The United States and the Socialist Republic of Vietnam have signed a memorandum of understanding (MOU) to enhance the safety of food, feed, drugs, and medical devices traded between the two nations.

The United States and the Socialist Republic of Vietnam have signed a memorandum of understanding (MOU) to enhance the safety of food, feed, drugs, and medical devices traded between the two nations.

The plan is the product of recent discussions between US Secretary of Health and Human Services (HHS) Mike Leavitt and senior Vietnamese officials in Hanoi, and it 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 interagency 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 lifecycle.

The MOU calls for cooperation in the following areas:

  • Information-sharing-The US and Vietnam governments will exchange information 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 (FDA) for use in aquaculture; training opportunities on key topics, such as safety surveillance of products after marketing; and timely information on potential or emerging issues of product safety.

  • Workshops and training-The two countries hope to conduct or participate in workshops or other training that concerns food, animal feed, and medical products, including those offered by international organizations. The two sides will also make efforts to find opportunities for joint training for food-borne illnesses and the oversight of food traded internationally.

  • Best practices in clinical trials-HHS/FDA and its counterpart agencies intend to cooperate on training and inspections of clinical trials for the development of medical products.

The MOU takes effect immediately, has an initial life of three years, and is subject to revision and renewal, contingent on the approval of both nations.

MOU between the US and Vietnam

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