Recently, Aidea Pharma (Stock Code: 688488.SH) brought a good news: Aidea has officially received the Good Manufacturing Practice (GMP) Certificate issued by the Tanzania Medicines and Medical Devices Authority (TMDA). This is Aidea Pharma’s first GMP certificate approved by a regulatory authority recognized as Maturity Level 3 (ML3) by World Health Organization (WHO), signifying that Aidea Pharma’s quality management system and manufacturing standards comply with internationally accepted requirements and laying a solid foundation for further expansion into the African market.

The WHO Global Benchmarking Tool (GBT) classifies the maturity of national regulatory authorities into four levels, ranging from ML1 (the lowest) to ML4 (the highest). ML3 represents a "stable, well-functioning, and integrated" medicine regulatory system, indicating systematic and internationally compliant operational capabilities across critical areas such as marketing authorization, GMP inspections, and post-marketing surveillance. By the end of 2025, only a limited number of regulatory authorities in Africa, including TMDA, had attained the ML3 level.

To promote Chinese innovative anti-HIV drugs to go global, Aidea Pharma has consistently aligned its operations with international standards and steadily advanced its international GMP certification programme. The GMP certificate Aidea Pharma previously obtained from Zanzibar laid a solid foundation for this breakthrough in Tanzania. The ML3 GMP certificate not only represents a significant leap in Aidea Pharma’s international certification level, but also serves as a “golden key” to expanding the African market, clearing major obstacles for subsequent products to enter the African market and serve people living with HIV in Africa.