关于主办第二十届国际药品监管机构会议（ICDRA）的提案征集通知
正文 · 中文译文
1. 背景与目的 国际药品监管机构会议（ICDRA）是由世界卫生组织（WHO）联合主办的一个旗舰级全球监管论坛。自1980年成立以来，ICDRA为各国药品监管机构负责人、高级监管人员、政策制定者、国际组织及主要利益相关方提供了一个独特的平台，用以交流知识和经验、加强国际监管合作、推动监管趋同与依赖。 ICDRA在识别和应对新兴监管挑战、促进监管优先事项对话以及为制定WHO规范、标准和指南提供信息以加强全球监管体系方面发挥着关键作用。 第二十届ICDRA将标志着全球监管合作的重大里程碑，提供一次机会来回顾四十多年的国际合作、总结成就与剩余挑战，并帮助塑造药品监管的未来。讨论预计将涉及关键优先事项，包括监管体系加强、趋同与依赖、数字化转型、创新以及公共卫生应急准备。 WHO特此邀请有意主办第二十届ICDRA的会员国根据本提案征集书附件一中所列要求表达意向并提交正式提案。 第二十届国际药品监管机构会议（ICDRA）预计将于2027年底举行，将由世界卫生组织（WHO）与选定的主办国共同组织。会议将主要以线下形式举行。 2. 第二十届ICDRA的目标 第二十届ICDRA旨在： 加强全球监管合作与协调统一； 推进监管体系建设，尤其是在低收入和中等收入国家（LMICs）； 促进信赖与工作共享机制； 应对新兴的监管挑战与机遇，包括数字化转型（如人工智能）、创新健康技术以及公共卫生应急准备； 促进国家监管机构（NRAs）、区域网络、国际组织和合作伙伴之间的合作； 确定战略优先事项和集体行动机会，以加强全球监管体系与合作。 3. 角色与职责 选定的主办国应按照附件一所述要求，提供必要的组织、后勤、技术和财政支持，以确保会议的成功举办。这还应包括与WHO密切协调，为沟通、媒体关系和会议宣传提供支持。 作为共同组织者，WHO将负责： 提出并与主办国商定会议的总体主题； 制定详细的技术和科学计划，包括确定演讲者和会议形式； 监督参与者注册并批准所有参与者的注册； 在整个组织过程中提供技术指导和战略协调； 与主办国协作，协调整体沟通策略，包括关键信息、品牌建设和宣传推广。 4. 意向表达与提案提交 考虑主办第二十届国际药品监管机构会议（ICDRA）的成员国，强烈建议尽早向世卫组织表达意向，自本提案征集通知发布之日起，不迟于2026年11月20日。 初步意向表达（EOI）应简要说明主办ICDRA的意向，确定拟议的主导机构（ preferably 国家监管机构），并在可用的情况下提供拟议地点和组织安排的初步信息。 这一初步步骤将使世卫组织能够与感兴趣的成员国接触，明确期望，并在必要时就准备正式提案的要求提供额外指导。提交意向表达（EOI）并不构成主办会议或保证入选的正式承诺。 正式提案应按照附件一所述的要求提交。 意向表达、正式提案及澄清请求应发送至： 收件人：icdra@who.int 抄送：bacha@who.int；minami.kawamata@who.int 世界卫生组织（WHO）将根据附件一中规定的要求审查收到的提案，并可在评估过程中酌情要求任何申请人进行澄清。WHO保留接受或拒绝任何提案的权利，并可在任何阶段修改或取消提案征集流程，且不因此对受影响的申请人承担任何责任。
正文 · 英文原文
1. Background and purpose The International Conference of Drug Regulatory Authorities (ICDRA) is a flagship global regulatory forum co-convened by the World Health Organization (WHO). Since its inception in 1980, ICDRA has provided a unique platform for heads of national regulatory authorities for medical products (NRAs), senior regulators, policymakers, international organizations, and key stakeholders to exchange knowledge and experiences, strengthen international regulatory cooperation, and advance regulatory convergence and reliance. ICDRA plays a pivotal role in identifying and addressing emerging regulatory challenges, facilitating dialogue on regulatory priorities, and informing the development of WHO norms, standards, and guidance to strengthen regulatory systems worldwide. The 20th ICDRA will mark a major milestone in global regulatory collaboration, offering an opportunity to reflect on more than four decades of international cooperation, take stock of achievements and remaining challenges, and help shape the future of medical products regulation. Discussions are expected to address key priorities, including regulatory systems strengthening, convergence and reliance, digital transformation, innovation, and preparedness for public health emergencies. WHO hereby invites Member States interested in hosting the 20th ICDRA to express their interest and submit formal proposals in accordance with the requirements outlined in Annex I of this Call for Proposals. The 20th ICDRA is expected to be held towards the end of 2027 and will be jointly organized by WHO and the selected host country. The conference will primarily be an in-person event. 2. Objectives of the 20th ICDRA The 20th ICDRA aims to: Strengthen global regulatory cooperation and convergence; Advance regulatory systems strengthening, particularly in low- and middle-income countries (LMICs); Promote reliance and work-sharing mechanisms; Address emerging regulatory challenges and opportunities, including digital transformation (e.g., artificial intelligence), innovative health technologies, and preparedness for public health emergencies; Foster collaboration among NRAs, regional networks, international organizations, and partners; Identify strategic priorities and opportunities for collective action to strengthen regulatory systems and cooperation worldwide. 3. Roles and responsibilities The selected host country will be expected to provide the necessary organizational, logistical, technical, and financial support to ensure the successful delivery of the conference, in accordance with the requirements outlined in Annex I. This should also include support for communications, media relations and conference visibility, in close coordination with WHO. As co-organizer, WHO will be responsible for: Proposing and agreeing with the host country on the overall theme of the Conference; Developing the detailed technical and scientific programme, including the identification of speakers and session formats; Overseeing participant registration and approving registration of all participants; Providing technical guidance and strategic coordination throughout the organizational process; Coordinating the overall communications approach, including key messages, branding and visibility, in collaboration with the host country. 4. Expression of interest and submission of proposals Member States considering hosting the 20th ICDRA are strongly encouraged to communicate their interest to WHO at the earliest opportunity, by 20 November 2026 from the publication of this Call for Proposals. An initial Expression of Interest (EOI) should briefly indicate the intention to host ICDRA, identify the proposed lead institution, preferably the national regulatory authority, and provide preliminary information on the proposed location and organizational arrangements, where available. This initial step will enable WHO to engage with interested Member States, clarify expectations and provide additional guidance on the requirements for preparing a formal proposal, if needed. Submission of an EOI will not constitute a formal commitment to host the conference or guarantee selection. Formal proposals should be submitted in accordance with the requirements outlined in Annex I. Expressions of interest, formal proposals and requests for clarification should be sent to: To: icdra@who.int Cc: bacha@who.int; minami.kawamata@who.int WHO will review the proposals received in accordance with the requirements set out in Annex I and may, at its discretion, ask any applicant for clarification as part of the assessment process. WHO reserves the right to accept or reject any proposal, and to modify or cancel the Call for Proposals process at any stage, without thereby incurring any liability to the affected applicant or applicants.