From: Global pharmaceutical regulation: the challenge of integration for developing states
 | Item discrimination | Item difficulty |
---|---|---|
GMP requirements are published by the government (5.05.03) | 1.89 | 0.08 |
(0.72) | (0.30) | |
MRA uses a computerized information management system (5.01.15) | 1.67 | 0.61 |
(0.60) | (0.30) | |
Government publishes National Good Pharmacy Practice Guidelines (5.05.11) | 1.50 | −0.84 |
(0.57) | (0.31) | |
Government publishes National Good Distribution Practice Guidelines (5.05.07) | 1.23 | −0.76 |
(0.46) | (0.27) | |
An MRA exists (5.01.02) | 1.20 | 1.34 |
(0.42) | (0.32) | |
Legal provisions establish the power and responsibilities of the MRA (5.01.01) | 1.14 | 1.38 |
(0.39) | (0.31) | |
Whistle-blowing mechanism for the pharmaceutical sector (3.01.16) | 0.95 | 0.04 |
(0.32) | (0.20) | |
A national medicines policy official document exists (3.01.04) | 0.77 | 0.78 |
(0.28) | (0.20) | |
Declaration of potential conflict of interests of experts (5.02.15S) | 0.75 | −0.25 |
(0.27) | (0.18) | |
MRA gets funds from regular government budget (5.01.11) | 0.66 | 0.77 |
(0.26) | (0.20) | |
Policy exists to manage and sanction conflict of interest (3.01.14) | 0.56 | −0.45 |
(0.23) | (0.17) | |
An assessment of the regulatory system was conducted within last five years (5.01.10) | 0.51 | 0.56 |
(0.23) | (0.17) | |
Pharmaceutical policy implementation is being regularly monitored (3.01.12) | 0.45 | −0.06 |
(0.21) | (0.16) | |
MRA is a semi autonomous agency (5.01.04.02) | 0.36 | −0.71 |
(0.23) | (0.17) |