Table 6 Posterior density of the measure of the regulation and monitoring of the private market model
From: Global pharmaceutical regulation: the challenge of integration for developing states
| Â | Aspect | Annual inspections | Regular inspections | ||
|---|---|---|---|---|---|
Item discrimination | Item difficulty | Item discrimination | Item difficulty | ||
Legal provisions for the promotion of medicines (5.07.01) | LF | 2.21 (0.70) | 2.02 (0.55) | 2.15 (0.68) | 1.98 (0.54) |
Manufactures required to be licensed (5.05.01) | LF | 2.06 (0.68) | 2.29 (0.59) | 2.05 (0.67) | 2.28 (0.58) |
Manufactures must comply with GMP (X5.05.02) | LF | 1.99 (0.62) | 1.54 (0.43) | 1.97 (0.61) | 1.53 (0.43) |
Pharmacovigilance part of MRA mandate (5.10.01) | PV | 1.75 (0.48) | 0.32 (0.28) | 1.75 (0.47) | 0.31 (0.28) |
Private wholesalers inspected (5.03.05.02) | SC | 1.74 (0.56) | 1.36 (0.39) | 1.81 (0.58) | 1.40 (0.41) |
Local manufactures inspected for GMP compliance (5.03.05.01) | SC | 1.72 (0.51) | 0.72 (0.31) | 1.77 (0.53) | 0.73 (0.31) |
Retail distributors inspected (5.03.05.03) | SC | 1.69 (0.54) | 1.36 (0.38) | 1.75 (0.56) | 1.37 (0.40) |
Legal provisions for ADR (5.10.03) | PV | 1.62 (0.46) | 0.05 (0.26) | 1.58 (0.45) | 0.05 (0.25) |
Wholesalers and distributors must be licensed (5.05.05) | LF | 1.52 (0.54) | 2.15 (0.50) | 1.50 (0.53) | 2.13 (0.49) |
Medicines registration always includes the INN (5.02.08) | LF | 1.25 (0.39) | 1.19 (0.29) | 1.20 (0.38) | 1.16 (0.28) |
Official standardized form for reporting ADRs is used (5.10.05) | PV | 1.17 (0.37) | 1.26 (0.30) | 1.16 (0.36) | 1.26 (0.29) |
National ADR database exists (5.10.06) | PV | 1.13 (0.31) | 0.07 (0.21) | 1.10 (0.31 | 0.07 (0.21) |
Marketer monitor safety and report to the MRA (5.10.02) | PV | 1.11 (0.33) | 0.05 (0.21) | 1.09 (0.32) | 0.05 (0.21) |
National ADR or pharmacovigilance advisory committee (5.10.10) | PV | 1.09 (0.33) | −0.60 (0.22) | 1.10 (0.33) | −0.60 (0.23) |
Importers required to be licensed (5.05.04) | SC | 1.02 (0.43) | 1.92 (0.39) | 0.98 (0.42) | 1.89 (0.38) |
Points of dissemination inspected (5.03.05.05) | SC | 0.94 (0.31) | 0.90 (0.23) | 0.97 (0.31) | 0.91 (0.23) |
Pharmacies are required to be registered (5.05.09) | LF | 0.89 (0.30) | 0.87 (0.23) | 0.88 (0.29) | 0.86 (0.22) |
ADR database is computerized (5.10.16S) | PV | 0.87 (0.26) | −0.09 (0.19) | 0.87 (0.26) | −0.10 (0.19) |
Training courses in pharmacovigilance exist (5.10.22S) | PV | 0.85 (0.27) | 0.41 (0.19) | 0.86 (0.27) | 0.41 (0.19) |
Distributors must comply with GDP (5.05.06) | LF | 0.82 (0.26) | −0.02 (0.18) | 0.80 (0.25) | −0.02 (0.18) |
Sampling of imported products for testing (5.04.02) | SC | 0.55 (0.23) | 0.64 (0.18) | 0.53 (0.23) | 0.63 (0.18) |
Publication of SPCs of registered medicines (5.02.12S) | LF | 0.46 (0.21) | −0.07 (0.16) | 0.47 (0.21) | −0.07 (0.16) |
Regularity of inspections | SC | 0.33 (0.11) | −0.38 (0.16) | 0.63 (0.25) | −0.79 (0.19) |
Importation only through authorized ports (5.04.03) | SC | 0.42 (0.21) | 0.54 (0.17) | 0.41 (0.21) | 0.54 (0.17) |
Pharmacists required to be registered (5.05.08) | LF | 0.17 (0.27) | 1.43 (0.22) | 0.14 (0.26) | 1.42 (0.22) |
Inspection of imported pharmaceutical products at ports of entry (5.04.04) | SC | 0.14 (0.20) | 0.35 (0.15) | 0.12 (0.19) | 0.35 (0.15) |