DOI: 10.51803/yssr.1937910 ISSN: 2149-4363

AI-Enabled Drug Discovery Platforms: Navigating the Confluence of Software, Medical Device, and Pharmaceutical Regulation in Sino-African Trade Relations

Klemens Katterbauer, Sema Yılmaz, Rahmi Deniz Özbay
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The integration of artificial intelligence into drug discovery platforms presents a fundamental challenge to established regulatory taxonomies worldwide, raising a deceptively simple question with profound implications: Should AI-enabled drug discovery platforms be regulated as software, as medical devices, or as pharmaceuticals? This article examines this regulatory trilemma through the dual lens of comparative global frameworks and Sino-African trade relations. The analysis reveals that major jurisdictions—including the United States, European Union, and China—have adopted hybrid approaches that defy simple categorization, with the FDA emphasizing Predetermined Change Control Plans for adaptive algorithms, the EU layering AI Act requirements atop Medical Device Regulation frameworks, and China advancing a specialized AI medical device guidance architecture. For African regulatory environments, where the African Medicines Agency is newly operational and most National Regulatory Authorities function at WHO Maturity Level 3, this global fragmentation presents both peril and opportunity. The article argues that China's emergence as a leading developer of AI-enabled drug discovery technologies, combined with its deepening pharmaceutical trade relationships across Africa under FOCAC frameworks, creates unprecedented possibilities for regulatory leapfrogging through Sino-African cooperation. By examining trade patterns, investment flows, and capacity-building initiatives, this research demonstrates that the regulatory classification question is not merely a technical matter of legal taxonomy but a strategic determinant of market access, technology transfer, and ultimately, health equity across the African continent. The article concludes with concrete recommendations for harmonized approaches, South-South regulatory cooperation mechanisms, and African-specific adaptation of global AI governance principles.

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