On December 6, 2025, Vietnam’s pharmaceutical landscape found itself at a crossroads, marked by a series of sweeping regulatory moves and an outpouring of public debate. In a single day, the Ministry of Health announced the licensing or renewal of nearly 600 drug products, unveiled a stringent new list of foreign pharmaceutical violators, and ignited national discussion over the future of health insurance drug coverage. The developments touch every corner of the country’s healthcare system, from drug manufacturers and importers to the millions of patients waiting in line at hospital pharmacies.
According to Vietnamplus, the Ministry of Health’s Drug Administration granted new circulation registration certificates to 404 domestically produced drug products, while renewing certificates for 42 more. These renewals included 26 drugs and raw materials extended for five years, with another 14 granted a three-year extension. The newly licensed and renewed drugs represent a wide array of therapeutic groups, including treatments for respiratory infections, osteoarthritis, cardiovascular diseases, hypertension, diabetes, cancer, as well as antiviral, antibiotic, pain relief, and anti-inflammatory medications. Notably, 98 drugs with proven biological equivalence were also announced, signaling a push for higher standards in generic medicine quality.
With these new approvals comes a stern reminder: manufacturing companies are required to comply with the dossiers they registered and must display Ministry-issued registration numbers on drug labels. The Drug Administration emphasized that facilities must maintain operational conditions throughout the license period and closely coordinate with treatment centers to monitor prescription drug use, safety, efficacy, and adverse effects in Vietnamese patients. For drugs whose licenses were renewed but whose labels or instructions have not yet been updated, companies have a 12-month window to comply, as stipulated by Circular 01/2018/TTBYT.
But while the regulatory machinery turns, the view from hospital corridors is less sanguine. A Tuổi Trẻ article published the same day captured the frustration of patients queuing at public hospitals, waiting to pay for and collect their health insurance (BHYT) medications. There’s a growing concern among patients and readers alike: many drugs—especially those for chronic conditions like hypertension and diabetes—remain outside the BHYT coverage list. As one reader, identified as Trang, commented, “Waiving hospital fees for cancer and dialysis patients is very humane. But what about the cost of treatment drugs? Many drugs are still not covered by health insurance.”
This sentiment is echoed by others who point to the planned increase in BHYT contributions—set to reach 6% of the base salary by 2030—as a necessary step, but only if it leads to higher quality care and broader drug coverage. Thanh Vân, another reader, argued, “To make health insurance truly effective, both financially and in terms of treatment quality, we need to study additional insurance packages aimed at improvement. We should move towards eliminating the BHYT drug list altogether, allowing doctors to prescribe flexibly so patients can buy their medications at linked pharmacies.”
Calls for reform extend beyond the composition of the drug list. Readers urge the Ministry of Health to ensure that presenting a BHYT card at a clinic guarantees service and care on par with private facilities. “People always hope that health insurance will improve the quality of examination and treatment, and expand the list and quality of medicines,” wrote another contributor. The hope is that future reforms will not only broaden access but also raise the standard of care, particularly for those suffering from chronic illnesses.
Meanwhile, a separate but equally pressing issue looms over the pharmaceutical sector: drug quality. On December 6, the Drug Administration released its 42nd list of foreign pharmaceutical companies whose imported drugs had failed to meet Vietnam’s quality standards. As reported by VTV, the list, updated as of November 13, 2025, includes 46 companies from a diverse array of countries. India leads with the largest number of violators, but companies from Bangladesh, China, Indonesia, South Korea, Pakistan, the United States, Italy, and Romania also appear. Some firms, such as Reman Drug Laboratories (Bangladesh) and CSPC Zhongnuo (China), have been repeat offenders since as early as 2013, with up to 12 violations each. Two American companies, ADH Health Products and Robinson Pharma, were cited for both quality violations and failing to comply with pre-inspection requirements.
For these 46 companies, every batch of imported drugs must now undergo 100% quality inspection before being allowed into circulation. The Drug Administration’s decision is rooted in a decade of monitoring and repeated warnings. The common thread among these firms is clear: their products have consistently failed to meet Vietnamese standards, necessitating the most stringent oversight. At the same time, the Ministry acknowledged progress elsewhere, with 98 companies from 16 countries being removed from the monitoring list after completing required pre-inspection periods without further violations.
Provincial health departments and drug management units have been instructed to ramp up supervision and enforce compliance, with violators subject to penalties under current regulations. The message is unmistakable: Vietnam will not tolerate substandard medicines, regardless of origin.
These regulatory and policy shifts come at a time when Vietnam’s healthcare system is under immense pressure to modernize and expand access. The Ministry’s decision to approve and renew hundreds of drug products—many made domestically—reflects both the country’s growing pharmaceutical capacity and the demand for affordable, high-quality medicines. At the same time, the ongoing debate over health insurance coverage and out-of-pocket costs underscores the challenges of balancing financial sustainability with universal access.
What’s next for Vietnam’s pharmaceutical and health insurance landscape? The answer may well depend on how these parallel efforts—tightening quality controls, expanding drug approvals, and reimagining insurance coverage—intersect in the months and years ahead. For now, patients, providers, and policymakers alike are watching closely, hoping that the reforms promised on paper will soon translate into tangible improvements in clinics and pharmacies across the nation.
