Issue No. 25
US and Vietnam Sign Memorandum of Understanding to Enhance Food and Medical Product Import Safety
Since Vietnam entered into the US-Vietnam Bilateral Trade Agreement (BTA) in 2001 and became the 150th member of the World Trade Organization (WTO) in 2007, the country has significantly expanded its involvement in the world economy and become increasingly committed to establishing greater transparency in its trade practices. The US, in particular, has worked closely with Vietnam to assist in the implementation of the BTA and to oversee the country's accession to the WTO, which has, in turn, resulted in greatly expanded business opportunities for American companies. This expansion is especially apparent in the integral role US firms have played in supplying Vietnam's growing demand for healthcare products.
Following the Vietnam Ministry of Health's 2001 issuance of its law, Approving the Strategy for Protection and Care of the People's Health in the 2001-2010 Period, the government embarked on a concerted effort to improve and update its healthcare system.(1) The increased need to upgrade medical services at hospitals as well as to establish new healthcare centers resulted in the substantial import of medical equipment and pharmaceutical products. Because local production of healthcare products is small in Vietnam, the market has relied almost entirely on imports.
More recently, the Vietnam government reinforced its commitment to both its growing economic ties with the US as well as to its public health protection goals, by signing a three-year renewable memorandum of understanding (MOU) with the US. The June 25th, 2008 MOU between the US Department of Health and Human Services (HHS) and the Vietnam Ministry of Health lays down "the Participants' intent to cooperate bilaterally regarding the safety of food and animal feed and the safety and effectiveness of medical products" in order to "to promote public health and help ensure products exported from either country are safe and meet applicable standards, including relevant global standards."(2)
In addition to the MOU's significance in demonstrating the Vietnam government's dedication to its strategic healthcare goals, the agreement also exemplifies the success of the new import-safety strategy created in November 2007 by a US Cabinet-level Interagency Working Group on Import Safety. The new strategy, chaired by HHS Secretary, Mike Leavitt, "calls for actively working with trading partners to help ensure they build quality into every step of a product's lifecycle."(3) The MOU specifically addresses the following areas:
- Information sharing - The US and Vietnam 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.(4)
Trade relations between the US and Vietnam have grown exponentially in the past several years, with both countries benefitting enormously economically and socially. The profound changes occurring in Vietnam's legal and regulatory systems are positively impacting the US as well as other countries seeking to increase their foreign commercial trade activities in Southeast Asia.
Approving the Strategy for Protection and Care of the People's Health in the 2001-2010 Period
Medical, Pharmaceutical and Cosmetic Products Distribution in Vietnam
Memorandum of Understanding between the Department of Health and Human Services of the United States of America and the Ministry of Health of the Socialist Republic of Vietnam Concerning Food, Animal, Feed, and Medical Products
Vietnam Pharmaceutical Regulatory Update
United States and Viet Nam Sign Agreement on the Safety of Food, Medical Products
US, Vietnam Conclude Review of Annual Bilateral Trade Agreement
US and Vietnam Join Hands for Drug Safety
Vietnam: Country Commercial Guide 2008
(1) (1)Vietnam Pharmaceutical Regulatory Update
(2) Memorandum of Understanding between the Department of Health and Human Services of the United States of America and the Ministry of Health of the Socialist Republic of Vietnam Concerning Food, Animal, Feed, and Medical Products
(3) United States and Viet Nam Sign Agreement on the Safety of Food, Medical Products
If you desire further information about this topic or any other regulatory issue, please feel free to contact me:
Diane R. Whitworth
DRW Research & Information Services, LLC
To be removed from this newsletter mailing list, please send an email to email@example.com and type "remove" in the subject line.