To what extent do you agree with the following members of the registration committee statement: “The 11 Strongly disagree are systematically and objectively selected based on the written criteria in force in your country?” Are there clear and comprehensive guidelines for the Describe clearly the mandate of the committee 1 Available publicly and in writing 0 committee’s decision making process? Describe the number of meetings it should convene 1 Describe procedures for decision-making 1 Include clear time limits for decision-making process for the 1 12 committee Describe the reporting structure 1 Decisions of meetings need to be publicly available 0 Percentage Correct 71% Score 0.71 Is there a formal appeals system for applicants who Yes/No 1 have drug applications rejected? Percentage Correct 100% 13 Score 1 To what extent do you agree with the following statement: and other benefits given to the officials “Gifts 14 Strongly agree in charge of medicines registration have no influence at all on the final decisions? II. PROCUREMENT OF DRUGS Question Criteria Written procedures publicly available 1 Does the government use transparent and explicit procedures for procurement of pharmaceutical Describe the internal process to be followed by staff on how to 1 products? process the bids Require the use of generic names 1 Require procurement to be based on the national essential 1 medicines list Require advertisement of tenders 1 Require that contract specifications be publicly available 0 1 Require that criteria for adjudication of tender be included as 1 part of the tender package Require that contract awards be made by the tender 1 committee Require that information on tender process and results are 1 made public (to the extent permitted by law) Percentage correct 89% Score 0.88 Is there written guidance for procurement office staff on Yes/No 1 the type of procurement method to be used for different Percentage correct 100% 2 types of products? Score 1 Is procurement done with an objective quantification Yes/No 1 method to determine the quantity of pharmaceuticals to Percentage correct 100% 3 be purchased? Score 1 Is there a formal appeals process for applicants who Yes/No 1 have their bids rejected Percentage correct 100% 4 Score 1 Is there a tender committee (TC)? If so, are the key There is a TC formally established 1 5 functions of the procurement office and those of the TC responsible for for restricted tenders 1 suppliers’ selection tender committee clearly separated? TC responsible for contract decisions 1
11 To what extent do you agree with the following statement: “The members of the registration committee are systematically and objectively selected based on the written criteria in force in your country?” Strongly disagree 12 Are there clear and comprehensive guidelines for the committee’s decision making process? Describe clearly the mandate of the committee Available publicly and in writing Describe the number of meetings it should convene Describe procedures for decision-making Include clear time limits for decision-making process for the committee Describe the reporting structure Decisions of meetings need to be publicly available 1 0 1 1 1 1 0 Percentage Correct 71% Score 0.71 13 Is there a formal appeals system for applicants who have drug applications rejected? Yes/No 1 Percentage Correct 100% Score 1 14 To what extent do you agree with the following statement: “Gifts and other benefits given to the officials in charge of medicines registration have no influence at all on the final decisions? Strongly agree II. PROCUREMENT OF DRUGS Question Criteria 1 Does the government use transparent and explicit procedures for procurement of pharmaceutical products? Written procedures publicly available Describe the internal process to be followed by staff on how to process the bids Require the use of generic names Require procurement to be based on the national essential medicines list Require advertisement of tenders Require that contract specifications be publicly available Require that criteria for adjudication of tender be included as part of the tender package Require that contract awards be made by the tender committee Require that information on tender process and results are made public (to the extent permitted by law) 1 1 1 1 1 0 1 1 1 Percentage correct 89% Score 0.88 2 Is there written guidance for procurement office staff on the type of procurement method to be used for different types of products? Yes/No 1 Percentage correct 100% Score 1 3 Is procurement done with an objective quantification method to determine the quantity of pharmaceuticals to be purchased? Yes/No 1 Percentage correct 100% Score 1 4 Is there a formal appeals process for applicants who have their bids rejected Yes/No 1 Percentage correct 100% Score 1 5 Is there a tender committee (TC)? If so, are the key functions of the procurement office and those of the tender committee clearly separated? There is a TC formally established TC responsible for suppliers’ selection for restricted tenders TC responsible for contract decisions 1 1 1
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