Recently, Jiangsu Aidea Pharmaceutical Group (stock code: 688488.SH) announced that it has officially received a GMP certificate for pharmaceuticals issued by the Tanzania Medicines and Medical Devices Authority (TMDA). This is the first GMP certificate approved by the World Health Organization (WHO) Maturity Level 3 (ML3) regulatory agency for Aidea Pharmaceutical, signifying that the company's quality management system and production standards meet international requirements and creating favorable conditions for expanding into the African market.

The World Health Organization's Global Benchmarking Tool (GBT) classifies the maturity of national drug regulatory agencies into four levels, from ML1 to ML4, from low to high. ML3 represents a "stable, well-functioning, and integrated" drug regulatory system, possessing systematic and internationally standardized operational capabilities in key areas such as marketing authorization, GMP inspections, and post-market surveillance. As of the end of 2025, only a few institutions in Africa, such as Tanzania's TMDA, have reached the ML3 level.
As a domestic pharmaceutical company focusing on anti-HIV drugs, Aidea Pharmaceuticals has been deeply involved in the field of anti-HIV innovation for many years. Two of its innovative anti-HIV drugs have been included in the National Medical Insurance Catalog and treatment guidelines. The company possesses strong R&D and production capabilities. The African market is a crucial part of the company's overseas commercialization strategy for innovative anti-HIV drugs. More than 70% of the world's AIDS patients are concentrated there, with Tanzania being one of the high-incidence areas, presenting a huge clinical demand for these drugs.
To promote the international market for domestically developed innovative HIV/AIDS drugs, Aidea Pharmaceuticals has consistently benchmarked against international standards and steadily advanced its GMP international certification process. Having previously obtained a GMP certificate in Zanzibar, it laid a solid foundation for this breakthrough. This latest achievement of obtaining the Tanzanian ML3 GMP certificate not only represents a significant leap forward in the company's international certification level but also provides a crucial key to expanding into the African market, clearing key obstacles for subsequent product entry into the local market and serving HIV/AIDS patients in Africa.
In the future, Aidea Pharma will take this certification as an opportunity to further deepen its market layout in Africa, provide local patients with new options for high-quality and efficient anti-HIV treatment, expand the company's development space, and help domestically produced innovative anti-HIV drugs reach the world stage.

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