Table 2.
Categories of ‘potential serious risk to public health’ objections raised leading to CMDh referrals and licensing failure during CMDh referrals
| Main category Subcategoriesa | Total, n | Licensing failure, n | Percent | Risk ratio (95 % CI) |
|---|---|---|---|---|
| Clinical (study design issues) | 64 | 21 | 33 % | Ref |
| Clinical (equivalence) | 64 | 21 | 33 % | 1.0 (0.6–1.6) |
| Bioequivalence/therapeutic equivalence not demonstrated | 39 | 15 | 38 % | 1.2 (0.7–2.0) |
| Bioequivalence/therapeutic equivalence not investigated in subgroup | 25 | 6 | 24 % | 0.7 (0.3–1.6) |
| Clinical (benefit risk concerns) | 83 | 8 | 10 % | 0.3 (0.1–0.6) |
| Insufficient data to support B/R in claimed indications | 34 | 7 | 21 % | 0.6 (0.3–1.3) |
| Safety concerns | 19 | 0 | 0 % | NA |
| Overall benefit/risk negative | 18 | 1 | 6 % | 0.2 (0.0–1.1) |
| Posology concerns | 12 | 0 | 0 % | NA |
| Quality | 38 | 3 | 8 % | 0.2 (0.1–0.8) |
| Concerns on quality or manufacturing parameters | 35 | 3 | 9 % | 0.3 (0.1–0.8) |
| Packaging concerns/medication errors | 3 | 0 | 0 % | NA |
| Regulatory/procedural | 40 | 2 | 5 % | 0.2 (0.0–0.6) |
| Concerns about SmPC wording | 30 | 1 | 3 % | 0.1 (0.0–0.7) |
| Administrative concerns (including patient leaflet /SmPC issues) | 10 | 1 | 10 % | 0.3 (0.0–2.0) |
| Multiple objections from different categories | 88 | 15 | 17 % | 0.5 (0.3–0.9) |
| Overall | 377 | 70 | 19 % |
aFor a detailed description of the categories, see supplementary information Table S2