TSE/BSE Attestation and Biological Materials Safety in Ethiopian Dossiers

1. Key takeaways

The Ethiopian non-IVD dossier sets two documentation requirements for biological source materials: Section 1.7 of Chapter 1 requires submission of a risk-free TSE/BSE attestation, and Section 3.4.8 of Chapter 3 requires a safety evaluation of biological source materials (human or animal). The two sit respectively in the administrative dossier and the evidence dossier: the former is a declarative document and the latter is a technical evaluation report, and neither can substitute for the other.

The administrative placement of the attestation has real consequences. Chapter 1 of EFDA/GDL/097 Version 002 consists entirely of eligibility documents (cover letter, agency agreement, fee payment proof, QMS, GMP, Certificate of Free Sale, TSE/BSE attestation, DoC), so a missing attestation returns the dossier at screening rather than generating a correction request during assessment. Meanwhile the technical evaluation under Section 3.4.8 addresses a broader question than TSE/BSE alone, covering viral safety, immunogenicity and sourcing control for both human and animal materials.

Manufacturers should therefore start with a materials inventory: does the product contain animal-derived or human-derived components, and if so which. Where the answer is no, a clear negative attestation should be filed rather than leaving the item silent. Where the answer is yes, three deliverables come into play: the attestation in Chapter 1, the source material safety report under Section 3.4.8, and, because of the animal contact, a biocompatibility evaluation under Section 3.4.6.

2. Legal basis

3. Expert insights

Insight 1: the TSE/BSE attestation is placed in the administrative dossier, which shows it is an eligibility document. Chapter 1 consists entirely of eligibility administrative documents (cover letter, agency agreement, fee payment proof, QMS, GMP, Certificate of Free Sale, TSE/BSE attestation, DoC). Its inclusion in Chapter 1 means that its absence leads to a return at the screening stage, not a request for correction during assessment. This distinction changes how the document should be managed: it belongs in the pre-submission gate alongside signatures and certificates, not in the technical workstream that can still be completed while the dossier is under review.

Insight 2: the scope of the TSE/BSE attestation is tied to animal-derived materials. The risk of transmissible spongiform encephalopathies (including bovine spongiform encephalopathy, BSE) is directly related to animal source materials. Devices containing animal-derived components (such as gelatin, collagen and animal-derived excipients) must submit the attestation; for products that contain no animal source materials, an explicit negative attestation should normally be made in the dossier rather than simply omitting the item. A documented negative declaration costs almost nothing to produce and eliminates the only interpretation under which a silent dossier item becomes a defect.

Insight 3: Section 3.4.8 covers both human-derived and animal-derived materials. The item is worded as safety of biological source materials (human/animal), and its scope is broader than TSE/BSE: beyond transmissible spongiform encephalopathies, it also involves viral safety, immunogenicity and sourcing control. Manufacturers of products with human-derived materials, such as collagen of human origin or human cell-derived components, should address donor screening, viral inactivation or removal validation and traceability of the supply chain, using the recognized standards list as the methodological reference for each of these elements.

Insight 4: the evaluation is independent of biocompatibility (Section 3.4.6). Section 3.4.6 evaluates the biological response of the body to contact with the device (cytotoxicity, sensitization, irritation and the like); Section 3.4.8 evaluates the safety of the material at its source. Devices containing animal-derived materials usually need to submit both. The two reports answer different questions and are prepared from different data: a device can pass biocompatibility testing on its final finished form yet still require source material documentation, and vice versa for the sourcing dossier of a material whose contact profile is benign.

Insight 5: the issuing party of the attestation must be accountable. Consistent with the DoC, the TSE/BSE attestation, as an administrative document, must be issued and signed by a party capable of bearing responsibility. An attestation issued by a raw material supplier must be accompanied by supply chain traceability information. In practice this means the manufacturer should collect supplier attestations plus the chain-of-custody records showing where the material was sourced, and then issue its own covering attestation signed by an authorized person, so the authority receives one accountable document supported by verifiable upstream records.

4. Practical recommendations

1. Determine first whether the product contains animal or human source materials: and decide from that whether the two documents apply.
2. Where the relevant materials are absent, issue an explicit negative attestation: do not simply omit the item.
3. Prepare the TSE/BSE attestation and the Section 3.4.8 report separately: they cannot substitute for each other.
4. Where animal-derived materials are present, prepare a biocompatibility evaluation in parallel.
5. Supplier attestations must be accompanied by supply chain traceability information: and state the issuing party.
6. Select the basis for viral safety and sourcing control from the recognized standards.

5. Verification checklist

• □ Whether the product contains human or animal source materials has been determined
• □ The risk-free TSE/BSE attestation (or a negative attestation) has been submitted in Chapter 1
• □ The safety evaluation of biological source materials has been submitted under Section 3.4.8
• □ Products with animal-derived materials have also submitted a biocompatibility evaluation
• □ Supplier attestations are accompanied by supply chain traceability information
• □ The methodological basis adopted has been stated according to the recognized standards

Regulatory information verified as of October 29, 2026. The TSE/BSE attestation and biological source materials evaluation items listed in this article are based on the current text of EFDA/GDL/097 Version 002 Sections 1.7 and 3.4.8; when the guideline is revised, they must be re-checked.

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