Table 1 Composition of State Regulatory Infrastructure
From: Global pharmaceutical regulation: the challenge of integration for developing states
3.01.04 | Equal to one if a national medicines policy official document exists. |
3.01.12 | Equal to one if pharmaceutical policy implementation is being regularly monitored/assessed. |
3.01.14 | Equal to one if a policy is in place to manage and sanction conflict of interest issues in pharmaceutical affairs. |
3.01.16 | Equal to one if there a whistle-blowing mechanism allowing individuals to raise a concern about wrongdoing occurring in the pharmaceutical sector of your country. |
5.01.01 | Equal to one if there are legal provisions establishing the powers and responsibilities of the Medicines Regulatory Authority (MRA). |
5.01.02 | Equal to one if there is a MRA. |
5.01.04.02 | Equal to one if the MRA is a semi autonomous agency. |
5.01.10 | Equal to one if an assessment of the medicines regulatory system has been conducted during the five years before the survey. |
5.01.11 | Equal to one if the MRA gets funds from regular budget of the government. |
5.01.15 | Equal to one if the MRA uses a computerized information management system to store and retrieve information on registration, inspections, etc. |
5.02.15S | Equal to one if legal provisions require declaration of potential conflict of interests for the experts involved in the assessment and decision-making for registration. |
5.05.03 | Equal to one if Good Manufacturing Practices (GMP) requirements are published by the government. |
5.05.07 | Equal to one if National Good Distribution Practice requirements are published by the government |
5.05.11 | Equal to one if National Good Pharmacy Practice Guidelines are published by the government |