EUROPEAN MEDICINE STANDARDS GROWING PRESENCE IN VIETNAM

Following a year of strategic expansion, European medicine-related companies are advancing their operations in Vietnam. Gregoris Charitonos, chairman of the European Standards Medicines Sector Committee under the European Chamber of Commerce in Vietnam, talked to VIR’s Tung Anh about what lies ahead.

How have legal changes made impacts on the performance of member companies of your sector committee in Vietnam?

Member companies demonstrated resilience and adaptability in a rapidly evolving business landscape in 2024. Despite global economic uncertainties, our member companies have achieved significant growth, driven by strong demand for high-quality European pharmaceutical products. Key highlights include regulatory progress, expansion and market penetration, investment in local capabilities, and sustainability initiatives.

Several member companies successfully obtained new product registrations, ensuring a more diverse portfolio of standard European medicines available to Vietnamese patients. Throughout the law drafting process, we have sent position papers to the relevant authorities to raise the voice of the off-patent pharmaceuticals industry.

Thanks to our continued effort, the amended pharma law is expected to help simplify the dossier for extension and variation registration from 2025, which will improve patient access to high quality generic medicines reducing public healthcare burden.

Many of our member companies expanded their presence in Vietnam, strengthening partnerships with local distributors, hospitals, and pharmacies.

Increased investments in research, clinical trials, and digital transformation have enhanced operational efficiency and patient accessibility. In 2023, we sponsored the Drug Administration of Vietnam during a two-day symposium on bioequivalence and clinical data evaluation in Hanoi, for evaluators, professors, and company members to address the current difficulties in dossier assessment and together come up with solutions.

Last month, we also co-held a conference on enhancing capacity of experts in evaluation of bioequivalence dossiers, at the University of Pharmacy and Medicines in Ho Chi Minh City, together with Sapharcen and Saigon Pharmaceutical Science Technology Centre.

Member companies place a strong emphasis on sustainability in line with the global sustainability goals. For example, they have incorporated environmentally friendly packaging and implemented green supply chain strategies.

Vietnam has taken commendable steps to improve its business environment, with notable progress in streamlining administrative procedures, digitalising regulatory processes, and enhancing transparency in pharmaceutical regulations. These efforts have facilitated faster market access for European medicines and improved the overall ease of doing business.

However, some challenges remain. Specifically, in regulatory consistency, while improvements have been made, unpredictable changes in regulations can still cause delays in product registration and market access. As one of the suggestions would be to use reliance with the European Medicines Agency.

Regarding pricing and reimbursement policies, further clarity and predictability in pricing policies would benefit member companies and ensure continued patient access to high-quality medicines.

Moreover, lengthy administrative processes, such as those in EU GMP publishing, by eliminating redundant approvals for documents that have been legally issued and authenticated. Specifically, once a document is issued and legalised, it should be accepted without further re-approval, as currently it may negatively impact supply to the hospital.

Also, government pharmaceutical policies evolve to treat generic medicines as equal to innovator molecules. While current policies largely emphasise innovator molecules, there is a pressing need to introduce measures that support and promote high-quality generic products. By ensuring that regulatory frameworks, funding, and quality assurance standards are equally applied to both categories, we can foster a competitive market that improves accessibility, affordability, and innovation across the healthcare sector.

Member companies expect greater harmonisation with international standards, faster approvals for new registrations, and a more predictable regulatory framework to sustain long-term growth, less unnecessary administrative procedures and equal policy treatment of the innovative and generic molecules. We will continue to advocate for the draft circular and decree guiding the amended Pharmaceutical Law, which is now open for comments.

Digital transformation and green growth are high on the agenda in the pharmaceutical industry. What are the priorities member companies give in this twin transition?

Our member companies have been actively implementing digital transformation and green growth initiatives in Vietnam, ensuring sustainable and efficient operations.

Key initiatives include e-prescriptions and telemedicine, AI and big data in pharma and smart distribution. In particular, many companies are collaborating with hospitals to integrate digital prescriptions and telehealth services, enhancing patient access to medicines.

AI-driven research, digital supply chains, and predictive analytics are improving efficiency and decision-making. Meanwhile, automated warehouse management and digital tracking systems are enhancing supply chain transparency and minimising waste.

In regard to green growth, several companies have introduced sustainable packaging solutions, reducing plastic waste and carbon footprints.

Members are also investing in green energy solutions, carbon offset programmes, and eco-friendly production facilities to align with global sustainability standards.

Value-added medicines, or so-called combo medicines, of our members not only improve the patients’ compliance and improve patients’ access to innovative therapies, but significantly limit waste, therefore have a great positive impact in terms of decreasing the environment pollution. On the other hand, companies implement sustainable waste disposal and recycling programmes within pharmaceutical operations.

Digitalisation and sustainability are no longer optional but essential for future growth, and member companies remain committed to these initiatives.

In business and investment among member companies in Vietnam, what will be their driving forces?

Vietnam’s pharmaceutical market is one of the most dynamic and competitive in Southeast Asia, with strong local and international players. While domestic pharmaceutical companies are expanding their capabilities, European pharmaceutical products continue to be highly valued for their quality, safety, and efficacy.

Vietnam’s market is growing rapidly, but regulatory approval times are still longer compared to Singapore and Malaysia, where procedures are more standardised. The country’s strategic location, fast-growing economy, and strong government focus on healthcare development make it an increasingly attractive market for long-term pharmaceutical investment. While competition is intense, Vietnam’s potential as a leading pharmaceutical hub in Southeast Asia remains strong, provided regulatory improvements continue.

Looking ahead to 2025 and beyond, member companies are highly optimistic about Vietnam’s long-term potential. More companies are expanding clinical research and trial capabilities in Vietnam, aligning with global standards. However, for a real kick-off in research and development, tax incentives and grants for life science in Vietnam are required. There is also a growing focus on biologic drugs, vaccines, and innovative therapies, addressing unmet medical needs.

While Vietnam is not yet a major pharmaceutical manufacturing hub, interest in local partnerships and technology transfers is increasing. This should be reflected in governmental actions, facilitating investments in pharmaceutical manufacturing and supporting export opportunities.

Public-private partnerships will continue to play a crucial role in healthcare policy development and accessibility improvements. Some companies are relocating or expanding operations in Vietnam due to its favourable investment climate, compared to markets with stricter price controls or regulatory hurdles.

Vietnam is positioned as a key pharmaceutical growth market in Southeast Asia, and our member companies will continue to drive innovation, sustainability, and patient-centric healthcare solutions in the country to have better patent access for high-quality generic medicines.

Source: Vietnam Investment Review

About STELLAPHARM

Stellapharm J.V. Co., Ltd. is currently known as one of leading generics pharmaceutical companies and strong manufacturers in Vietnam. Established in 2000, Stellapharm was built on the foundation of a manufacturing factory in Vietnam and formed a joint venture with a partner from Germany. We focus on both prescription drugs and non-prescription especially in cardiovascular diseases, anti-diabetics drugs, etc. Products of Stellapharm are now used by millions of patients in more than 50 countries worldwide.

The company is globally recognized for its quality through our facilities have been audited and approved by stringent authority like EMA, PMDA, Taiwan GMP, local WHO and others.

Additional information for this article: Stellapharm J.V. Co., Ltd. – Branch 1
A: 40 Tu Do Avenue, Vietnam – Singapore Industrial Park, An Phu Ward, Thuan An City, Binh Duong Province, Vietnam
T: +84 274 376 7470 | F: +84 274 376 7469 | E: info@stellapharm.com | W: www.stellapharm.com