African Regulatory Agencies and the Acceptance of Observational Studies in Traditional Use Registration

As traditional medicines and herbal products gain wider recognition across global healthcare systems, regulatory frameworks are evolving to balance public health protection with respect for long-standing traditional use. In Africa, regulatory agencies such as SAHPRA and CAPA play a critical role in shaping how traditional medicinal products are evaluated and registered.

A growing area of regulatory focus is the acceptance of observational studies as supportive evidence for traditional use registration. Understanding how African regulators view, assess, and apply such data is essential for companies, researchers, and regulatory professionals working with herbal and traditional products.

Regulatory Landscape in Africa for Traditional Medicines

African regulatory systems recognize that traditional medicinal products often have a history of safe use spanning decades or centuries, even when randomized controlled trials are limited or unavailable. As a result, regulators have developed pathways that allow non-interventional and real-world evidence, including observational studies, to support product registration.

SAHPRA oversees the regulation of medicines, medical devices, and complementary medicines in South Africa. Its framework for complementary and traditional medicines emphasizes:

• Evidence of traditional use
• Safety substantiation
• Plausible efficacy supported by scientific or observational data

At the continental level, CAPA aims to harmonize regulatory approaches across African Union member states. CAPA encourages convergence on data requirements, including the structured use of observational and real-world evidence for traditional medicines.

Role of Observational Studies in Traditional Use Registration

Observational studies are particularly relevant for traditional medicines because they reflect real-world usage patterns, community-based outcomes, and long-term safety observations. Unlike interventional trials, these studies do not alter standard practice, making them well suited to documenting traditional use.

African regulators consider observational studies valuable when they:

• Demonstrate consistent use within defined populations
• Document safety outcomes over time
• Support claimed indications aligned with traditional knowledge

Both SAHPRA-aligned national frameworks and CAPA-led harmonization efforts recognize observational data as complementary evidence, especially when supported by literature, pharmacological rationale, and quality documentation.

Acceptance Criteria for Observational Studies

For observational studies to be accepted in traditional use registration, regulators typically assess the scientific robustness and relevance of the data rather than applying pharmaceutical clinical trial standards.

Key considerations include:

• Clearly defined study objectives and population
• Transparent methodology and data collection processes
• Consistency between observed outcomes and traditional claims
• Adequate documentation of safety and adverse events

Regulators also expect observational data to be contextualized within existing ethnobotanical records, published literature, and mechanistic understanding, ensuring that claims are not exaggerated or misleading.

Best Practices for Submitting Observational Study Data

Successful submissions align observational evidence with regulatory expectations rather than treating it as standalone proof. Best practices include:

• Structuring observational reports using clear scientific narratives
• Linking real-world outcomes to traditional indications
• Supporting observations with published literature and biological plausibility
• Demonstrating traceability of data sources and ethical considerations

Early engagement with regulatory guidance and harmonized frameworks promoted through CAPA can significantly improve submission outcomes across multiple African markets.

What You Will Learn from This Course

Enhanced Regulatory Knowledge

Participants gain a comprehensive understanding of the African regulatory landscape, with specific focus on how agencies such as SAHPRA and CAPA approach traditional medicine registration and evidence evaluation.

Observational Study Acceptance

The course provides clarity on acceptance criteria, helping participants understand how observational studies are reviewed, contextualized, and integrated into regulatory decision-making.

Practical Tips and Strategies

Attendees learn actionable strategies for compiling, structuring, and presenting observational study data in a manner that meets regulatory expectations and supports successful traditional use registration.

Closing Perspective

The acceptance of observational studies by African regulatory agencies reflects a progressive and context-aware approach to traditional medicine regulation. By acknowledging real-world evidence and historical use, agencies like SAHPRA and CAPA are enabling safer, more transparent pathways for traditional products to reach the market.

For stakeholders in herbal and traditional medicine development, mastering these regulatory expectations is not only a compliance requirement it is a strategic advantage in building credible, evidence-backed products for the African healthcare ecosystem.

Dr Pravin Badhe
Founder and CEO of Swalife Biotech Pvt Ltd India/Ireland.