Sourcing Reference Drugs from Overseas for Bioequivalence Studies

In bioequivalence studies (BE studies), reference drugs play a pivotal role in ensuring the accuracy and validity of trials. But what exactly is a reference drug?

What is a Reference Drug?

According to Circular 07/2022/TT-BYT a reference drug is a drug that a generic drug aims to replace in treatment. Typically, reference drugs are either innovator products or drugs that have been granted marketing authorization with complete data on efficacy, safety, and quality.

What drugs are commonly used as Reference Drugs?

1. List of Original Brand-Name Drugs: Drugs selected from the list of original brand-name drugs announced by the Ministry of Health, or drugs that have been granted marketing authorization with complete data on quality, safety, and clinical efficacy.

2. Drugs Approved by Stringent Regulatory Authorities (SRAs):

• Innovator drugs that have not been granted marketing authorization in Vietnam but have been approved by one of the SRAs and are being marketed in those countries;
• Drugs that have been approved by one of the SRAs and are being marketed in those countries.

3. Drugs which are prequalified by the World Health Organization (WHO).

Challenges in Sourcing Reference Drugs from Overseas:

• Finding Suppliers: Many businesses struggle to find reliable suppliers, making it difficult to access products. The requirement for complete documentation, including invoices, is also a significant challenge when selecting a supplier.
• Complex Import and Export Procedures: The import and export of drugs can be time-consuming and laborious, extending the duration of research and testing.
• Language Barriers: Language differences can hinder communication with overseas suppliers, complicating negotiations and cooperation.

Solutions from Bene Esse

To overcome these challenges, partnering with reliable suppliers is crucial. Bene Esse Pte Ltd is one such supplier, providing reference drugs from SRA countries, with headquarters in Singapore and a branch in Malaysia. Bene Esse specializes in supplying imported drugs for distribution or research purposes to register imported drugs and pharmaceutical ingredients.

Why Choose Bene Esse’s Drug Sourcing Service?

• Assured Quality: Reference drugs are supplied in accordance with international standards, meeting the requirements for clinical trials.
• Clear Origin: Ensures the origin of the drugs and provides valid documentation as required by the Drug Administration of Vietnam (DAV).
• Dedicated Service: Bene Esse’s team of experienced professionals will support you throughout the entire drug purchasing process, from sourcing to delivery.

The Reference Drug Purchasing Process at Bene Esse

If you are facing difficulties in finding reference drugs for your BE study, please contact Bene Esse (assistant@vttmbeneesse.com.sg). Bene Esse’s experts are always ready to assist and advise you, helping you overcome challenges and achieve your research goals. With a commitment to quality and dedicated service, Bene Esse is a reliable partner in your product development journey.