For many health supplement products, scientific literature on individual ingredients is not sufficient to demonstrate the claimed effects of the finished product. Where required by law, or where a business wishes to build direct evidence on its own product, an efficacy testing report can play an important role in regulatory documentation and product-development dossiers.

Under Article 4 of Circular No. 43/2014/TT-BYT of the Ministry of Health, certain categories of health supplements are required to have an efficacy testing report on human health before circulation or product declaration in accordance with applicable regulations.

The Academy of Medical Sciences, Vietnam provides services for the design, conduct, and preparation of efficacy testing reports using clinical research methods, with the aim of generating objective and transparent scientific evidence that can support product registration, development, and commercialization activities.

According to applicable Ministry of Health requirements, efficacy testing reports may be required for certain product categories, including:

• Products making new claims that have not yet been recognized.
• Products containing new active ingredients not yet permitted for use.
• Health supplements with new formulations that lack equivalent scientific evidence.
• Certain products of plant or animal origin introduced to the market for the first time with new ingredients.
• Other cases as required by the relevant regulatory authority.

Beyond legal requirements, many businesses proactively conduct efficacy studies to build competitive differentiation, increase product credibility, and develop product claims supported by scientific evidence.

An efficacy testing report can provide value beyond regulatory compliance and may support long-term product development.

Key benefits include:

• Generate direct scientific evidence on the business's own product.
• Support completion of product declaration and registration dossiers in accordance with applicable requirements.
• Evaluate product effects using data collected from research participants.
• Strengthen brand credibility and confidence among consumers, professionals, and partners.
• Support the development of scientific materials, product dossiers, and evidence-based communications.
• Provide data for research and development (R&D), formulation improvement, and product-portfolio expansion.
• Support commercial value and access to markets that place greater emphasis on scientific evidence.

Depending on the study objective and product characteristics, the report may include:

• Study objectives and hypotheses.
• Study design.
• Participant inclusion and exclusion criteria.
• Efficacy assessment methods.
• Clinical, laboratory, or functional outcome measures relevant to the intended product effects.
• Safety assessment during product use.
• Statistical analysis of the data.
• Scientific conclusions regarding product efficacy and safety.

All data are managed and analyzed using objective procedures designed to support accuracy, transparency, and traceability.

The Academy of Medical Sciences, Vietnam conducts the service using a standardized process designed to support scientific quality and project timelines.

1. Consult on applicable regulatory requirements and define the testing objectives.
2. Develop the study protocol and statistical analysis plan.
3. Obtain research ethics review in accordance with applicable requirements, where required.
4. Recruit volunteers who meet the study criteria.
5. Conduct the study and follow participants according to the protocol.
6. Collect and manage the data.
7. Perform statistical analysis and interpret the results.
8. Complete the efficacy testing report and support the business in the appropriate use of the research results.

The Academy of Medical Sciences, Vietnam not only prepares study reports but also works with businesses to develop a broader scientific evidence base for their products.

We provide integrated support including:

• Strategic consulting to select an appropriate testing model for each product.
• Study design based on evidence-based medicine principles.
• Access to a diverse volunteer network to support timely recruitment.
• A multidisciplinary team with expertise in medicine, pharmacy, nutrition, biostatistics, and clinical research.
• Data-management and statistical-analysis systems designed to support objectivity and traceability.
• Support in using research results appropriately in product dossiers, scientific materials, and market-development activities.

Each efficacy testing report prepared by the Academy of Medical Sciences, Vietnam is intended to generate reliable scientific evidence that supports professional requirements and evidence-based product development. We support businesses from protocol development and study conduct through data analysis and final reporting, while recognizing that outcomes may be positive, neutral, mixed, or unfavorable and that product claims must remain consistent with the evidence and applicable regulations.