WHO - World Health Organization Regional Office for The Western Pacific

06/05/2025 | News release | Distributed by Public on 06/05/2025 17:14

Safe and effective medical products in Viet Nam: WHO highlights 10 years of progress with support from the Government of Korea

Safe and effective medicines, vaccines and medical devices of assured quality are critical for any health system.

Patients and health professionals must rely on regulatory authorities to legally authorize that these biomedical products meet national or relevant international standards.

Since 2015, Viet Nam has strengthened the systems that regulate medicines, vaccines and devices, with support from the Government of the Republic of Korea's Ministry of Food and Drug Safety, through the World Health Organization (WHO).

Collaboration with the Republic of Korea was particularly important in supporting Viet Nam's successful response to the COVID-19 pandemic. Around the world, national regulatory authorities faced immense pressure to make rapid decisions on vaccine approvals, despite limited scientific data. Support from the Republic of Korea and WHO's Viet Nam Country office and Western Pacific Region helped decision makers in Viet Nam navigate the challenges and contributed to the country's ability to authorize vaccines in a timely and informed manner. Similarly, this support enabled Viet Nam to buy rapid antigen and PCR tests to ensure fast and accurate diagnoses.

In September 2024, Viet Nam adopted the Pharmaceutical Law, whose development was supported by the Republic of Korea and WHO. The Law incorporates lessons from the pandemic, international best practice and streamlines regulatory approvals. These changes reinforce the legal authority of the Viet Nam National Regulatory Authority, enabling it to more effectively ensure the quality, safety and efficacy of medicines and vaccines.

WHO supported the law's development with technical advice, policy briefs, and sponsoring and participating in key consultations, including a major consultation with nearly 1000 participants including representatives from all relevant stakeholders, provincial health facilities, drug quality centres, institutes and the pharmaceutical industry.

"WHO is enormously grateful for the generous support from the Government and people of the Republic of Korea over the past decade, including in times of crisis, to help ensure people have access to safe and high-quality medicines, vaccines and medical devices," WHO Representative in Viet Nam Dr Angela Pratt said.

"With this support, Viet Nam has been able to build its capacity to prevent and respond to health emergencies, regulate more effectively, improve its manufacturing and procurement to avoid stock-outs, develop the Pharmaceutical Law and much more."

"Viet Nam can be proud of the progress it has made in the past decade toward building a strong and trustworthy regulatory system based on legislation, policy and good practice that aims to ensure people's safety and well-being. WHO is very pleased to have been able to contribute to these efforts."

Republic of Korea Minister of Food and Drug Safety Oh Yu-Kyoung said, "The Republic of Korea is delighted to mark 10 years of progress in health regulation with Viet Nam. We are proud to play an active role in collaborating with WHO to improve the health of people in Viet Nam through regulatory capacity strengthening, as we work together for a safer and healthier world."

Among the highlights of two countries' collaboration are enhancing staff capacity to implement and enforce regulatory policies, boosting good laboratory practices so that more labs are equipped with updated methodologies and accredited, and other work to align processes with WHO standards and international best practices.

The Republic of Korea's support has helped strengthen Viet Nam's National Regulatory Authority, which is composed of the Drug Administration of Viet Nam, the Viet Nam Administration of Disease Prevention, the National Institute for Quality Control of Vaccine and Biologicals, the Administration of Science, Technology and Training, the National Institute of Drug Quality Control and the National Information and Adverse Drug Reaction Center.

These agencies play varied roles, including protecting against substandard and falsified medical products, which are a significant global problem. They can be found in all countries, impacting all types of medical products, including life-saving treatments like vaccines, antibiotics and cancer therapies. In 2017, WHO estimated that 1 in 10 medicines in low- and middle-income countries failed quality control tests, suggesting the product was substandard or falsified. This can lead to serious health risks, treatment failures and even death.

The economic burden is also substantial, with billions of dollars lost annually due to ineffective treatments, increased health-care costs and loss of productivity. For patients, the consequences are dire: relying on ineffective or harmful products can exacerbate illnesses, lead to prolonged suffering and contribute to drug resistance, making diseases harder to treat.

To tackle sub-standard, fake and counterfeit medical products, WHO supports global cooperation, robust regulations, legal frameworks and public awareness.

The Partnership between WHO and the Republic of Korea's Ministry of Food and Drug Safety is also contributing to regulatory system strengthening in Cambodia, the Lao People's Democratic Republic and Mongolia.

A 6-month-old baby girl held by a man receives a measles vaccine shot as part of the government's immunization campaign addressing outbreaks across Viet Nam. Credit: Loan Tran / WHO

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