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本地药品生产能力评估报告.pdf

上传人: p****n 编号:614168 2025-02-19 29页 1.24MB

1、LOCAL MANUFACTURING OF MEDICINES REPORT ON CAPACITY ASSESSMENT SAPICS 2024IntroductionRationale/Problem Statement 1.Mismatch between market demand and supply2.85%of essential meds not manufactured locally 3.Imports account for 70%of the total Kenya Pharma Market Size4.20%of the total health expendit

2、ure for HPT are from imports which accounted to KES 76 bn in 2020Objectives of the Assessment1.To understand the profile and current scope of the local pharmaceutical industries in Kenya2.To assess the extent to which essential medicines are currently manufactured locally3.To gather market intellige

3、nce on current markets served4.To evaluate the prevailing local manufacturing capacities5.To identify challenges faced by local manufacturers6.To identify proposed solutions by the local manufacturers to inform strategies for increasing local production of medicinesThe President pronouncement in Oct

4、ober 2023-At least 50%of health products and technologies in essential lists should be sourced locally by 2026MethodologySampling Sampling frame of 41 local manufacturers was obtained from the PPB.4 manufacturers had closed permanently5 had closed for Corrective and Preventive Action(CAPA)2 companie

5、s had changed their manufacturing scope from human to veterinary medicine30 sites were identified for the assessmentData Collection ProcessAssessment done from 5th February to 16th Feb 2024Team composition:3 to 4 members drawn from DHPT,ARC,KHF and HPA.Team-Leads from DHPTConsent and confidentiality

6、 forms were signed by both parties;A copy was to retained on siteData collection tools:Online tool was filled on Kobocollect app(using tablets)Excel template were filled and submitted to the Team leadsKEY FINDINGSCompany Profiles&Scope Products Range&VolumesCompany Capacity&TechnologyMarkets Served/

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本文是关于肯尼亚本地制药业产能评估的报告,由SAPICS 2024发布。报告指出,市场需求与供应不匹配,85%的基本药品未在本地生产,进口药品占到2020年肯尼亚制药市场的70%。评估目标包括了解本地制药业的现状、评估本地生产基本药品的程度、收集市场情报、评估现有制造能力、识别制造商面临的挑战,并探索增加药品本地生产量的策略。 关键数据包括:本地制药公司从20年前至今有增长趋势,但只有23家是本地所有,2家是合资企业;本地制造的药品范围广泛,但部分产品如抗感染药物、心血管药物和皮肤科药物需求较大;本地生产能力尚未充分利用,例如非β内酰胺类平板的年安装产能为88.6亿片,实际年产量为77.4亿片;本地制药公司面临诸多挑战,如缺乏政府激励措施、硬货币短缺、投资融资困难、原材料供应不稳定、工作环境不理想和严格的监管要求。 制造商提出的解决方案主要是希望得到政府支持,以及获得信贷/贷款等金融支持。报告建议应采取措施以增加本地制药业的生产能力和竞争力。
本地制药业现状如何? 本地生产的药品与市场需求匹配吗? 本地制药业面临哪些挑战和解决方案?
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