EMA优先药物的研发及近两年的优先药物发展情况

PRIME: Priority Medicines优先药物

7 w4 R& A8 {' T1 Y/ w+ r$ B) U3 OPRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier.
“优先药物”是EMA启动的一个旨在支持未满足医疗需求的药物开发计划。该计划以加强与由前途药物研发人员的相互交流和早期对话为基础，以便优化研发计划、加快对这类药物的审评，从而使药物更早的被患者获得使用。
! [* u! }0 |- ]* A* g) B% |# xThrough PRIME, the Agency offers early and proactive support to medicine developers to optimise the generation of robust data on a medicine’s benefits and risks and enable accelerated assessment of medicines applicati**.
9 n4 z3 g7 f% I  P, _通过“优先药物”计划，药监部门能够为药品研发人员提供早期的和前瞻性的支持，以便优化药物风险收益的可靠数据，并能够加快药物申请的评估速度。
  o: z6 D! o" G" ?0 j/ J' HThis will help patients to benefit as early as possible from therapies that may significantly improve their quality of life.
7 l3 Q% |4 |5 ]* `这将帮助病人尽早从可能显著改善他们生活质量的治疗中受益。
Accelerated assessment
加速审评
% J5 ?, I& Q5 s& Q% GPRIME builds on the existing regulatory framework and tools already available such as scientific advice and accelerated assessment. This means that developers of a medicine that benefited from PRIME can expect to be eligible for accelerated assessment at the time of application for a marketing authorisation.
“Prime”是基于现有的监管框架和工具而推行的新机制，例如科学建议和加速审评。这意味着可以从PRIME中获得最直接的收益药物研发人员在申请药品上市许可时，可以预期获得加速审评的资格。
6 l+ J% P% ?/ sFostering early dialogue
培养早期对话
By engaging with medicine developers early on, PRIME is aimed at improving clinical trial designs so that the data generated is suitable for evaluating a marketing-authorisation application.
. _8 F% m8 r6 Z4 _PRIM的目的是通过早期参与到药品研发过程中促进临床试验设计，以便使生成的数据适用于上市许可申请的审评。
Early dialogue and scientific advice also ensure that patients only participate in trials designed to provide the data necessary for an application, making the best use of limited resources.
4 M! Y" i# p# f( B3 I0 O前期的对话和科学建议也能够确保仅参与到临床设计中的患者为申请提供必要的数据，更好的利用有效的资源。
Key benefits for applicants
) b) p& F% L  H! \2 U; J( m/ l对于申请人来说关键的收益是
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Once a candidate medicine has been selected for PRIME, the Agency will:

一旦候选药物被选为“优先药物”，监管部门将会

appoint a rapporteur from the Committee for Medicinal Products for Human Use(CHMP) or from the Committee on Advanced Therapies (CAT) in the case of an advanced therapy to provide continuous support and help to build knowledge ahead of a marketing-authorisation application;

人用药委员会（CHMP）或者先进治疗委员会（CAT）会指派一位专员，在药物被认定为先进治疗药物的情况下为企业提供持续不断的支持，帮助上市许可申请之前建立知识信息。

organise a kick-off meeting with the CHMP/CAT rapporteur and a multidisciplinary group of experts, so that they provide guidance on the overall development plan and regulatory strategy;

与CHMP/CAT报告人及多学科专家小组组织召开启动会，以便能为药物的总体研发方案和注册策略提供指导。

assign a dedicated contact point;

指定一个专用的接触点

provide scientific advice at key development milestones, involving additional stakeholders such as health-technology-assessment bodies, to facilitate quicker access for patients to the new medicine;

在关键的研发程碑为企业提供科学的建议，包括更多的利益相关者（例如健康-技术-评估组织）接洽，以便于让病人更早的获得新药。

confirm potential for accelerated assessment at the time of an application for marketing authorisation.

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在提交上市申请时与企业确认获得加速审评的可能性。

Eligibility criteria
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6 r- w5 w0 r  v$ Z5 @* \; zThe scheme focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment opti**. These medicines are c**idered priority medicines by EMA.
该药物侧重于能够提供超出现有治疗方法的重大治疗优势或者为目前没有治疗方案的病人提供益处。这样的药物被EMA认为具有优先药物资格。
% y2 H2 E* a4 m! ~, NTo be accepted for PRIME, a medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data.
基于早期临床数据，被授权为优先药物的药品，必须要显示其对未满足医疗需求的病人的带来益处的潜力。
2 V1 ?2 L* P$ pKey figures关键点
The charts below provide key figures on PRIME eligibility requests.
以下图表提供了优先药物资格要求的关键点。
They show the cumulative recommendati** up to the latest CHMP meeting.
* j# B5 C) s* p& R8 y! q9 O他们在最近的CHMP会议上展示了累积的建议。
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ps：图表参见附件
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