On August 22, 2024, Orioled Hub Institute of Pharmaceutical Technologies (OHI) and Thong Nhat Hospital officially signed a cooperation agreement to establish a Bioequivalence and Clinical Trials Center. This strategic partnership marks a significant milestone in the Vietnamese pharmaceutical industry, promising to accelerate clinical trials and enhance the global acceptance of bioequivalence study results, thereby propelling the Vietnamese pharmaceutical sector onto the international stage.
In the face of global pharmaceutical integration, accelerating research and development based on modern technology and techniques is essential for the Vietnamese pharmaceutical industry to gain a competitive edge. This will also provide opportunities to access high-quality pharmaceuticals and proactively meet the healthcare needs of the community.
Bioequivalence studies are conducted to compare the bioavailability of a new drug product with that of an approved reference product. This comparison serves as the basis for selecting domestic drug substitutes without relying on imported drug supplies. By using bioequivalent drugs, we can predict similar therapeutic outcomes as the reference drug.
Bioequivalence is a critical issue for the development of Vietnam’s pharmaceutical industry. It requires the collaboration of experts, policymakers, and the support of advanced equipment, standardized procedures, and appropriate methodologies. Currently, Vietnam only has six bioequivalence testing centers licensed by the Drug Administration of Vietnam. Of these, only two centers operated by the Institute of Drug Quality Control Ho Chi Minh city and the National Institute of Drug Quality Control are fully operational and provide widespread services. Given this situation, completing a bioequivalence study can take more than two years, causing significant challenges for pharmaceutical companies.
The joint venture between Orioled Hub Institute of Pharmaceutical Technologies (OHI), Thong Nhat Hospital, and Equilab (Indonesia) to establish a Bioequivalence and Clinical Trials Center marks a significant milestone. This collaboration aims to create a center that adheres to both Vietnamese Ministry of Health and European Medicines Agency quality standards. By shortening the duration of bioequivalence trials and enhancing the international acceptance of results, this center promises to propel the Vietnamese pharmaceutical industry onto the global stage.
This collaboration marks a significant milestone in Orioled Hub’s journey, contributing to the completion of its product and service supply chain, both now and in the future.