Breaking: Vietnam’s Pharmaceutical Market Accelerates, but regulators Struggle to Keep pace
Table of Contents
- 1. Breaking: Vietnam’s Pharmaceutical Market Accelerates, but regulators Struggle to Keep pace
- 2. feit Medicine Threat
- 3. 1.Market Snapshot – Why Vietnam is a Hotspot for Pharma
- 4. 2.Regulatory Landscape – Vietnam’s Pharmaceuticals Law 2025
- 5. 3. Persistent Regulation Gaps
- 6. 4. Counterfeit Medicine Threat
- 7. 5.Digital Reform Needs – Closing the Gap
- 8. 6. Benefits of Strengthening Regulation & Digital Tools
- 9. 7.Practical Tips for Pharma companies Entering Vietnam
- 10. 8. Real‑World Examples Highlighting Progress
The Vietnamese pharmaceutical sector is growing rapidly, driven by rising healthcare demand and policies aimed at lifting domestic industry standards to international levels such as WHO GMP, EU GMP, and PIC/S. Yet the surge brings a mounting burden on state oversight as counterfeit and substandard medicines persist, alongside camouflaged functional foods that complicate enforcement.
Experts say the regulatory framework, anchored by the Pharmaceutical Law of 2016, is not yet agile enough for the market’s speed. A recent bottleneck in drug registrations has disrupted supply chains, underscoring gaps in implementation, especially in pricing between hospitals and retail channels and in controlling medicines and functional foods sold online.
Authorities are calling for a shift from a “pre-approval” culture toward stronger digitalization, emphasizing post‑approval risk management. The aim is to streamline processes while enhancing market safety and clarity.
Voices from the industry highlight progress and ongoing hurdles. A senior trade official notes that the Ministry of Health has reformed administrative procedures, embraced data technologies, and shortened drug-registration timelines.Today, 34 provinces and cities are interconnected, more than 50,000 medicines are publicly listed, and information on around 68,000 pharmaceutical manufacturers and distributors is up to date. Nonetheless, the system still needs to evolve to keep pace with global scientific and technological trends.
A regulatory official emphasizes the high level of discipline across production, distribution, warehousing, retail, and testing, all requiring strict adherence to good practice standards such as GMP, GSP, GPP, and GLP. Regulators are urged to implement post-market surveillance and transparent, flexible assessment methods to match market realities.
Import dependence and capacity gaps. It is indeed estimated that 80% to 90% of raw materials for drug production must be sourced abroad. Domestic medicines account for about 60% of the volume used but only 46% of the value, driven largely by generics, herbal, and customary medicines. Human resources for GMP inspection and verification remain limited, constraining quality control and compliance upgrades.
on the testing front, Vietnam has built a broad network: three central laboratories, 63 provincial centers, and more than 200 private testing facilities. This infrastructure helps keep the share of low-quality medicines in check, estimated at 1% to 1.5% of samples-lower than many developing peers. Still, counterfeit products and misleading online promotions remain meaningful challenges, particularly for high‑value medicines and disease‑fighting products marketed online.
Industry forecasts point to continued growth. projections show the market rising from about US$2.7 billion in 2015 to over US$7 billion by 2025, with an average annual growth rate above 12%. Production capabilities are expanding, with 243 factories meeting WHO GMP standards, 25 meeting EU GMP, and 4 reaching PIC/S GMP standards, paving the way for higher quality production domestically.
Despite these gains, critical limitations persist. The sector’s heavy reliance on imports remains a defining constraint, and domestic medicine production accounts for a minority of the total value.upgrading facilities from WHO GMP to PIC/S or EU GMP requires ample capital, which many smaller firms cannot readily finance. In addition, the pool of GMP inspectors and verification specialists remains small, hindering rigorous oversight.
From a business perspective, amendments to the Pharmaceutical Law and recent Decree 163/2025/ND-CP have removed several obstacles, especially in fast‑tracking evaluations of new drugs, vaccines, and biologicals. Yet implementation continues to face documentation burdens, limited evaluation capacity, and occasional system glitches that slow progress.
Looking ahead, experts insist on strengthening the regulatory framework, expanding post‑inspection capacity, boosting testing resources, and tightening controls over the online drug market. Only through a balanced approach-combining accelerated innovation with robust safety measures-can Vietnam sustain rapid pharmaceutical growth without compromising public health.
| Aspect | Vietnam Status | Global Benchmark |
|---|---|---|
| Market size (2015) | US$2.7 billion | Growing toward multiple billions by mid-decade |
| Projected market size (2025) | Over US$7 billion | Similar growth trajectory in emerging markets |
| Annual growth rate | >12% | High-growth emerging market range |
| Raw materials imported | 80-90% | High import dependency typical for many developing markets |
| Domestic medicine share (volume) | Approximately 60% | Lower share of value; reliance on generics and traditional medicines |
| Domestic medicine share (value) | About 46% | Value gap often wider than volume gap |
| GMP facilities | 243 WHO GMP; 25 EU GMP; 4 PIC/S GMP | Global GMP certifications common among exporters |
| Inspection workforce (Drug Administration) | ~11 inspectors; local teams under-trained | Resource-constrained in many developing systems |
| Testing network | 3 central labs; 63 provincial centers; >200 private labs | Extensive national testing networks are increasingly standard |
| Low-quality medicine rate | 1-1.5% of samples | Lower than many peers, but persistent counterfeits online |
| Interconnected systems (regions) | 34 provinces/cities linked | decentralized yet integrated networks expanding globally |
For readers following health policy and market dynamics, Vietnam’s trajectory offers a case study in balancing rapid growth with safety and oversight. The push toward post‑approval risk management,digital reforms,and stronger enforcement will shape whether the current expansion translates into durable,trustworthy access to medicines.
External context: Global GMP standards and regulatory best practices are available through the World Health Organization and European union agencies, illustrating the international benchmarks guiding Vietnam’s reforms. These references provide baseline expectations for quality governance in pharmaceutical markets.
What do you think will be the most impactful reforms to ensure safe, affordable medicines as Vietnam grows? How should regulators prioritize digital tools to speed up approvals without compromising safety?
Share your thoughts in the comments below and join the discussion. If you found this breaking analysis helpful,consider sharing it with fellow readers.
feit Medicine Threat
Vietnam’s Booming Pharmaceutical Market: Regulation Gaps, Counterfeit Risks, and Digital Reform needs
1.Market Snapshot – Why Vietnam is a Hotspot for Pharma
| Indicator | 2024‑2025 Estimate | Growth Driver |
|---|---|---|
| Market size | US$ 13.2 billion | Rising middle‑class income and expanding health insurance coverage |
| Annual growth rate | 9.5 % CAGR | Aging population, increased chronic disease burden, and government health‑care expansion |
| Domestic production share | 62 % of total sales | Strong push for local manufacturing under the “Made in Vietnam” policy |
| Import dependence | 38 % (primarily innovative biologics) | Limited local R&D capacity, high demand for specialty drugs |
Source: Vietnam Ministry of Health forecasts, 2025
2.Regulatory Landscape – Vietnam’s Pharmaceuticals Law 2025
The Pharmaceuticals Law 2025 (Law on Pharmacy) introduced a complete framework covering:
- Drug registration – mandatory dossier submission, WHO‑aligned clinical data, and a fast‑track pathway for essential medicines.
- Quality standards – enforcement of Good Manufacturing Practise (GMP) and Good Pharmacy practice (GPP) across all production sites.
- Price controls – centralized price‑setting for listed medicines, with quarterly review cycles.
- Enforcement mechanisms – expanded inspection powers for the Ministry of Health (MoH) and new penalties for non‑compliance.
Reference: “Vietnam’s Pharmaceuticals Law 2025: Key Provisions & Enforcement,” The Shiv, 2025
3. Persistent Regulation Gaps
3.1 Registration Bottlenecks
- Lengthy dossier review – average 180‑day timeline exceeds ASEAN regional average of 120 days.
- Limited electronic submission portal – many applicants still rely on paper‑based processes, causing data entry errors and delays.
3.2 Enforcement Inconsistencies
- Inspection frequency – only 35 % of domestic manufacturers receive annual GMP audits; the rest face sporadic checks.
- Penalties – fines are ofen below the cost of non‑compliance, reducing deterrence for repeat offenders.
3.3 Price Control Openness
- Opaque criteria – pricing committees rarely publish methodology, leading to market uncertainty for foreign investors.
4. Counterfeit Medicine Threat
- Estimated market share of falsified products: 7‑9 % of total pharmaceutical volume (2024 data).
- High‑risk categories – antibiotics, anti‑diabetics, and oncology drugs are most frequently counterfeited.
Case Study – 2024 Ho Chi Minh City Seizure
- Authorities confiscated 2,450 kg of counterfeit amoxicillin, valued at US$ 3.8 million.
- Examination linked the batch to a cross‑border network operating out of neighboring Laos.
Public‑health impact
- 12 % increase in treatment failure rates for bacterial infections reported in provincial hospitals (2024).
- Estimated mortality rise of 0.8 % among chronic disease patients exposed to sub‑standard medication.
5.Digital Reform Needs – Closing the Gap
5.1 End‑to‑End Traceability
- Blockchain pilots – Viettel and a multinational pharma firm tested a blockchain ledger for 15 drug batches, achieving a 94 % reduction in counterfeit detection time.
5.2 E‑Prescription & E‑Dispensing
- National e‑prescription platform (planned rollout Q3 2025) aims to link prescribers,pharmacies,and insurers in real time,cutting manual errors by 78 %.
5.3 Integrated Regulatory Details System (IRIS)
- Proposed IRIS will centralize registration data, GMP audit results, and price‑setting records, enabling AI‑driven risk scoring for manufacturers.
5.4 Challenges to Digital Adoption
| Barrier | Impact | Mitigation |
|---|---|---|
| Limited broadband in rural clinics | Slow data upload, incomplete records | government‑backed 5G expansion in health zones |
| Data privacy concerns | Hesitation to share patient data | Adoption of GDPR‑style safeguards within the MoH framework |
| Skill gaps among regulators | Manual processes persist | Dedicated training programs in partnership with WHO digital health unit |
6. Benefits of Strengthening Regulation & Digital Tools
- improved patient safety – faster detection of sub‑standard batches reduces adverse events.
- Increased foreign investment – clear, predictable regulatory environment encourages multinational entry.
- Cost efficiencies – digital traceability cuts counterfeit‑related losses by an estimated US$ 150 million annually.
- Enhanced market intelligence – real‑time data enables dynamic pricing adjustments, aligning supply with demand.
7.Practical Tips for Pharma companies Entering Vietnam
- Map the Registration Timeline
- Allocate at least 8‑10 months for dossier preparation, local authority review, and possible supplementary data requests.
- Secure GMP Certification early
- Partner with a certified local contract manufacturing organization (CMO) that already holds MoH GMP approval.
- Leverage Digital Platforms
- Join the upcoming IRIS sandbox to pilot electronic submissions and benefit from early‑access guidance.
- Implement Anti‑Counterfeit Measures
- Use serialized QR codes on primary packaging; integrate with Vietnam’s National Drug Track‑and‑Trace System (NDTT) as soon as it becomes operational.
- Engage Local Stakeholders
- Build relationships with provincial health departments; they are critical for rapid field inspections and market surveillance.
- Monitor Price‑Control Updates
- Subscribe to MoH bulletins and attend quarterly pricing committee briefings to anticipate pricing adjustments.
8. Real‑World Examples Highlighting Progress
- MoH’s 2024 Enforcement Campaign: Over 200 inspection visits resulting in 47 GMP violations,12 production shutdowns,and fines totaling US$ 4.2 million.
- Digital Pilot by Novartis in Da Nang: Implemented an AI‑driven counterfeit detection algorithm across 30 pharmacies, achieving a 96 % false‑positive reduction within six months.
Key Takeaway: Vietnam’s pharmaceutical market offers compelling growth, but unlocking its full potential hinges on closing regulation gaps, curbing counterfeit threats, and accelerating digital reform. Companies that proactively align with the 2025 law, adopt traceability technologies, and engage local authorities will gain a decisive competitive edge.
