New GMP Requirements for Pharmaceutical Manufacturers in Vietnam

In order for Vietnam to better ensure the standards of their pharmaceutical products, Vietnam’s Ministry of Public Health has begun implementing new regulations for Good Manufacturing Practice (GMP) requirements. These regulations will be based on World Health Organization (WHO) standards and will be fully effective for pharmaceutical manufacturing sites in 2006 and pharmaceutical material companies in 2010. These new regulations should increase export opportunities for pharmaceutical companies in Vietnam, since most countries only accept internationally-recognized GMP standards of pharmaceuticals.

The first regulation for WHO GMP compliance in Vietnam went into effect in November 2004. This regulation stipulates that all pharmaceutical manufacturing sites built after November 2004 must meet WHO GMP compliance before they can obtain a manufacturing operator’s license. Vietnam’s Department of Pharmaceutical Management (DPM) will be in charge of GMP inspections and granting GMP certificates. These licenses will be valid for two years. Pharmaceutical manufacturing sites which have already met Association of Southeast Asian Nations (ASEAN) GMP standards may continue production with the ASEAN GMP certification. However, once their ASEAN GMP certification expires, the factory must obtain WHO GMP certification.