In Vietnam, a signed contract is not always an enforceable one. Many foreign investors are surprised to learn that a fully negotiated and executed contract can be declared invalid by a court, simply because it failed to meet specific, overlooked, legal formalities. This critical gap between a contract’s formation (the moment of signing) and its […]
Vietnam’s pharmaceutical industry is entering a decisive turning point. Stricter quality standards, shorter recall deadlines, and tighter compliance requirements are no longer abstract ideas.
They are becoming legal reality with Circular 30/2025/TT-BYT. For foreign investors and international pharmaceutical companies, this shift represents both a challenge and an opportunity: the challenge of higher compliance costs, and the opportunity to capture growth in testing services, R&D partnerships, and high-quality manufacturing.
In my experience supporting foreign investments at Viettonkin, I have seen that the greatest risks often come not from the written laws themselves, but from how they are applied in practice.
That is why helping our clients anticipate and adapt to these unwritten rules has become the foundation of long-term success in Vietnam’s evolving pharmaceutical market.
Key Takeaways:
- Circular 30/2025/TT-BYT will introduce stricter quality standards and faster recall deadlines for all pharmaceutical products, impacting the entire pharmaceutical market.
- Foreign investors and international pharmaceutical companies must prioritize understanding the new compliance landscape to ensure continued growth.
- While compliance costs may rise, new regulations create significant growth opportunities in testing services, R&D partnerships, and high-quality manufacturing for many companies.
- Strategic local partnerships are essential for pharma companies to navigate government agencies and ensure smooth market entry and long-term growth.
- Success in Vietnam's evolving pharmaceutical market hinges on treating regulatory compliance not as a hurdle, but as a core strategy for sustainable growth.
I. The New Playing Field: How Circular 30/2025 Reshapes Vietnam’s Pharmaceutical Sector
The Vietnamese government’s goal is clear: align the local pharma industry with international standards. This will improve public health and boost competitiveness for all companies involved. Circular 30/2025/TT-BYT is the primary instrument for this change.
From my experience helping hundreds of companies navigate regulatory shifts, this is a moment of both risk and opportunity.
This is not just about updating paperwork. An expert analysis from Tilleke & Gibbins (2025) confirms that the new guidelines will enforce stricter drug quality standards and significantly shorten timelines for recalls.
This is a major challenge that puts immense pressure on the supply chain management of all pharmaceutical companies. This move from the Ministry of Health replaces a previous circular, demanding a higher level of vigilance from all companies in the pharma sector.
For foreign investors, clarity is paramount. The official English translation of the circular, which legal portals like LuatVietnam (2025) provide, becomes an essential tool for foreign direct investment. However, the text alone is not enough.
Understanding its practical application requires on-the-ground experience, especially when dealing with the many companies that form the local supply chain.
II. Vietnam’s Pharmaceutical Industry: A Market Of Contrast And Opportunity
Vietnam’s pharmaceutical market is one of the most dynamic in Southeast Asia, reflecting trends seen across the global pharmaceutical market. It's a key market among developing countries, driven by rising incomes and a growing demand for quality healthcare.
Yet, it remains a challenging landscape for many companies where local manufacturing capabilities are still catching up.
The demand for high-quality generic drugs, biologics, and other pharmaceutical products is soaring. However, over half of the active ingredients are still imported, creating vulnerabilities.
For smaller pharma companies, these stricter regulations present a hurdle. The high costs of upgrading facilities to meet Good Manufacturing Practice (GMP) standards can be overwhelming for these companies.
This is where proactive compliance becomes a lifeline. I think of our client whose permit was at risk. The challenge wasn't just the timeline; it was a complex regulatory issue threatening one of the many international companies seeking growth in Vietnam.
Our team’s emergency coordination with government agencies saved their investment and achieved a 30% faster processing time, a precedent that has since benefited other companies.
III. From Compliance Burden To Competitive Advantage: Opportunities In The New Era
While the new rules demand more, they also create fertile ground for growth and investment for prepared pharma companies.
1. Building Trust And Opening Export Doors
Meeting international standards is no longer just a compliance exercise; it’s a powerful market differentiator. For our clients, achieving these standards has built trust with healthcare professionals and opened export opportunities.
This is the essence of healthcare innovation in Vietnam today, turning quality control into a competitive advantage for companies.
2. A Booming Market For Testing And R&D Partnerships
The intensified focus on quality creates a market gap, presenting a prime opportunity for companies specializing in GMP/GLP testing. Furthermore, to close the R&D gap, Vietnamese pharma companies are seeking partnerships. This is driving investment in clinical trials for new molecular entities and other breakthrough medicines.
With its large population, Vietnam is an attractive location for clinical trials, a sector poised for growth as more companies look to diversify research.
3. Emerging Growth Segments And A Reshaped Global Landscape
The pharmaceutical/drug business has several high-growth segments, many of which were profoundly shaped by the recent global health crisis. The pandemic massively impacted the global pharmaceutical industry, accelerating R&D at an unprecedented rate and reshaping global spending on healthcare.
The race for a vaccine highlighted the power of scientific breakthroughs, and the lessons learned from that period are now being applied to other infectious diseases.
For all companies, the post-crisis landscape has created a new operational basis. The supply chain disruptions during the public health emergency forced a strategic rethinking, underscoring the critical need for local production, a huge opportunity for companies to invest in manufacturing within Vietnam.
This experience has made the entire pharma industry more resilient, a quality that was tested again in the previous year. The world after COVID 19 is simply different for all companies, and their strategies continue to reflect this new reality.
The market for generic drugs is also set for expansion. The looming patent expiration for several blockbuster branded drugs from top pharma companies like Merck & Co and Eli Lilly presents a massive opportunity.
The loss of market exclusivity due to patent expiration can lead to lower sales for a drug company, which must be partially offset by higher sales from other pharmaceutical products in their product portfolio.
For Merck & Co, its patent protection on key drugs is vital, but the company also relies on its animal health and diagnostics division, where revenues rose in the same period that drug sales fell in the previous year. The constant cycle of patent expiration is a key focus for all leading companies.
A looming patent expiration forces companies to innovate in their core therapeutic areas. A company like Merck & Co consistently invests in R&D for new molecular entities across multiple therapeutic areas.
IV. Your Strategic Blueprint For Success In Vietnam’s Pharma Market
Navigating this new landscape requires a robust, proactive strategy focused on compliance and partnership for all companies.
1. Navigating Compliance With An Audit-Ready Mindset
The starting line is being audit-ready from day one. I remember the relief in a client’s voice after we resolved their emergency audit. The audit began with 24-hour notice, threatening their license.
Our team’s systematic approach, leveraging documentation and agency relationships, resulted in a clean audit for one of the many companies we protect. This experience helped us develop protocols that now proactively protect all our client companies.
2. Local Partnerships: Your Key To Smoother Market Entry
For foreign companies, trying to go it alone is a costly mistake. Collaborating with local manufacturers and experienced advisory firms is critical. As Thư Viện Pháp Luật (2025) outlines legal requirements, a local expert translates them into actionable steps for companies.
V. The Future Is Bright, But Preparation Is Key
Vietnam's pharmaceutical industry is on an upward trajectory. The alignment with global standards and strong government support create a powerful engine for long-term, sustainable growth. The global pharmaceutical market, especially the competitive US market, sets a high bar.
In the fourth quarter of the previous year, many leading companies reported that increased sales in some therapeutic areas were partially offset by challenges in others. Global sales continue to show a positive growth profile.
Investors must prepare for risks. For a major player like Merck & Co, even one weak quarter can affect net sales compared to the previous year. The focus remains on innovation in key therapeutic areas to drive growth and deliver new drugs.
The development of molecular entities is critical for long-term success. The growth in therapeutic areas such as oncology and cardiovascular renal metabolic diseases is a key focus for companies like Merck & Co. Success in this pharmaceutical market hinges on a diverse product portfolio and robust patent protection.
When a patent expires, it tests the resilience of even the largest companies. Over the past two decades, the global pharmaceutical industry has seen this cycle repeat. Even with strong performance in the previous year, all companies plan for future patent cliffs.
VI. Conclusion
As Vietnam’s pharmaceutical sector enters a phase of regulatory transformation, Viettonkin Consulting stands ready as your strategic partner, helping international businesses turn compliance pressures into meaningful competitive advantages.
With many years of experience advising foreign direct investment, our multidisciplinary team spanning legal, tax, compliance, audit, and advisory services has supported numerous multinational corporations through Vietnam’s regulatory landscape while seizing growth opportunities in testing, R&D, and high-quality local manufacturing.
At Viettonkin, we understand that sustainable success in Vietnam’s pharmaceutical market is built upon:
- A proactive, audit-ready compliance strategy
- Trusted partnerships with local industry and authorities
- A forward-looking vision focused on long-term growth
Let us guide your business confidently through this evolving regulatory environment, transforming challenges into opportunities for lasting achievement.
You may also be interested in our recent article on Navigating Vietnam’s Customs Clearance: Essential Insights for Foreign Investors, which explores practical steps to streamline import and export procedures in Vietnam.
Frequently Asked Questions
1. What is the biggest mistake foreign pharma companies make when entering Vietnam?
In my experience, the biggest mistake is underestimating the importance of practical relationships with regulatory bodies. Many pharmaceutical companies have perfect legal paperwork but fail because they don't understand the specific expectations of local authorities, where a trusted local partner becomes invaluable.
2. Realistically, how long does it take for companies to become fully compliant with Circular 30/2025?
While legal transition periods are defined, achieving full operational compliance can take 6 to 12 months for most companies. This includes upgrading facilities, training staff on new recall procedures, and validating supply chains, all of which must be done meticulously to ensure growth.
3. Should my drug company partner with a local firm or navigate compliance alone?
Based on hundreds of cases, partnering with a local expert is the most effective way to protect your investment. The cost of a compliance crisis, a failed audit, or a rejected permit for any of the companies involved far outweighs the investment in securing experienced guidance from the start.
