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.

Advertisements

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

%d bloggers like this: