Barriers to WHO prequalification of similar biotherapeutic insulin.

IF 8.4 2区 医学 Q1 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Bulletin of the World Health Organization Pub Date : 2024-11-01 Epub Date: 2024-09-25 DOI:10.2471/BLT.24.291804
Henry Mj Leng, Jicui Dong
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Abstract

Objective: To identify the barriers preventing manufacturers of similar biotherapeutic human insulin from submitting their products to the World Health Organization (WHO) for prequalification.

Methods: We used a self-administered questionnaire to collect data from companies producing similar biotherapeutic human insulin. We included questions about the insulin products manufactured, knowledge of WHO prequalification requirements, export of the products and compliance with good manufacturing practices. Companies had the possibility to provide additional relevant information. We sent the questionnaire to 20 manufacturers in total. We evaluated responses and organized the data into themes.

Results: We had a response rate of 55% (11/20 companies). Five broad themes emerged: (i) manufacturers and products; (ii) expressions of interest awareness and participation; (iii) need for technical assistance and training; (iv) market and supply chain challenges; and (v) approval for good manufacturing practices. The most important reasons for manufacturers' lack of response to WHO's expression-of-interest invitation were absence of a mechanism to guarantee return on investment, and perceived complexity of prequalification requirements for insulin-similar biotherapeutic products.

Conclusion: To encourage greater participation in the WHO prequalification programme, international procurement agencies associated with the programme should consider establishing a platform to enter into advance purchasing agreements with manufacturers. In addition, WHO's Local Production and Assistance Unit should provide companies with ongoing technical assistance on the development of their human insulin products and improvement of their production facilities to comply with the WHO requirements for good manufacturing practices.

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世卫组织预审类似生物治疗胰岛素的障碍。
目的确定阻碍类似生物治疗人胰岛素生产商将其产品提交世界卫生组织(WHO)进行资格预审的障碍:我们采用自填问卷的方式,从生产类似生物治疗人胰岛素的公司收集数据。其中包括有关胰岛素产品的生产、对世界卫生组织预审要求的了解、产品出口和良好生产规范的遵守情况等问题。企业还可以提供其他相关信息。我们共向 20 家制造商发出了调查问卷。我们对答复进行了评估,并将数据整理成主题:答复率为 55%(11/20 家公司)。出现了五大主题:(i) 制造商和产品;(ii) 表示有兴趣了解和参与;(iii) 对技术援助和培训的需求;(iv) 市场和供应链挑战;以及 (v) 对良好生产规范的认可。制造商对世卫组织的意向书邀请缺乏回应的最重要原因是缺乏保证投资回报的机制,以及认为胰岛素类似生物治疗产品的资格预审要求很复杂:为鼓励更多国家参与世卫组织资格预审计划,与该计划有关的国际采购机构应考虑建立一个平台,与生产商签订预购协议。此外,世卫组织的当地生产和援助股应向各公司提供持续的技术援助,帮助其开发人胰岛素产品和改进生产设施,以符合世卫组织的良好生产规范要求。
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来源期刊
Bulletin of the World Health Organization
Bulletin of the World Health Organization 医学-公共卫生、环境卫生与职业卫生
CiteScore
11.50
自引率
0.90%
发文量
317
审稿时长
3 months
期刊介绍: The Bulletin of the World Health Organization Journal Overview: Leading public health journal Peer-reviewed monthly journal Special focus on developing countries Global scope and authority Top public and environmental health journal Impact factor of 6.818 (2018), according to Web of Science ranking Audience: Essential reading for public health decision-makers and researchers Provides blend of research, well-informed opinion, and news
期刊最新文献
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