Breaking News on Contract Research, Manufacturing & Clinical Trials

Headlines > Commercial Services

US and Vietnam form drug safety pact

By Kirsty Barnes , 26-Jun-2008

The US and Vietnam have agreed on a strategy to increase the safety and efficacy of food, drugs and medical devices traded between the pair.

The move is the latest in the US Food and Drug Administration's (FDA's) bid to restore the faith of the nation in its ability regulate the quality of food and drugs entering its borders after a string of high profile scandals.

 

 

 

On Tuesday the two countries signed a memorandum of understanding (MoU) pledging to protect the health of their citizens through bilateral cooperation and exchange.

 

 

 

Detailing the agreement to the media, the FDA said that the MoU covers three key areas - information sharing, workshops and training, and best practices in clinical trials.

 

 

 

Specifically, the US and Vietnam governments have pledged to dutifully exchange information on their respective regulatory systems, divulging details such as laws and regulations; guidance documents; and potential or emerging issues of product safety.

 

 

 

In addition the two countries will exchange training opportunities on key topics, such as safety surveillance of products after marketing, as well as make efforts to find opportunities for joint training. They also intend to cooperate on training and inspections of clinical trials.

 

 

 

Prompting the move is the fact that import safety has become a key priority for the FDA, after it has been much criticised of late over its lack of oversight over the quality of the escalating number of food and drug imports reaching US shores, from Asia in particular.

 

 

 

The agency has already set in motion plans to form closer ties with the Chinese regulatory authorities, from where the majority of Asia's drug products originate, and establish an agency presence in the country by the end of the year. The watchdog also signalled that it had similar plans to do so with other Asian countries in the near future, in particular, the region's other dominant player, India.

 

 

 

Meanwhile, Vietnam has entered the FDA's radar as the trade relationship between the US and the country has greatly accelerated in recent years.

 

 

 

"Trade between our two nations has grown exponentially in recent years… with this agreement, we're increasing our joint efforts to ensure the safety of goods," said the FDA's Department of Health and Human Services (HHS) deputy secretary Tevi Troy.

 

 

 

This MoU is effective immediately and is valid for three years, at which point there is opportunity to extend the cooperation for a further three years, although it can also be repealed by either party at any time. Each nation is responsible for funding its own activities.

Key Industry Events

 

Access all events listing

Our events, Events from partners...