EU Regulation No. 536: A Quick Primer for Life Sciences Companies

欧盟法规第536号:生命科学公司快速入门

2022-01-25 11:00 United Language Group

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At long last, the European Union (EU) Clinical Trials Information System (CTIS) is ready for action. That means that on January 31, 2022, EU Regulation 536 goes into effect. Although there is a one-year transition period for sponsors conducting new clinical trials, forward-thinking companies should seek to meet the new requirements sooner rather than later. At United Language Group, we’re here to help you navigate this complex regulatory environment and support you every step of the way towards compliance. What is EU Regulation No 536? A Brief Summary EU Regulation No 536 requires clinical trial sponsors and contract research organizations (CROs) to submit clinical trial information using a new centralized portal and database. This regulation was enacted in 2014 and originally set to roll out in 2015; however, delays in launching the portal mean that it’s now going into effect on January 31, 2022. The Goal: A Centralized Review Process Sometimes, change is good. For example, this regulation streamlines procedures, better leverages existing and “local” data, and is expected to make it easier to conduct clinical trials in the EU. Clinical trial applications, rules, and review times will be harmonized, ultimately making it easier for sponsors and CROs to manage the process and stay compliant. However, some aspects of clinical trials will still be governed by national laws, depending on the countries involved. For example, each member state may have its own language requirements, as well as its own laws relating to fees, biological samples, GMOs, data protection, and radiological procedures. Focus on Transparency and Public Accessibility Transparency is another important aspect of the new regulation. Most of your clinical trial information and data will need to be publicly accessible to everyone in the EU via the database. Additionally, Plain Language Summaries (PLS) must be available within a year of the trial completion date in the official language of each country the study was conducted in. A PLS is a summary of the trial information that’s written and presented so that a layperson can easily understand it. Under EU Regulation 536, these are no longer simply “nice to have.” Now, they’re essential for compliance. All of this may mean additional translation is required, above and beyond what you currently provide. ULG is here to help you navigate this. Our Recommended Strategies to Successfully Implement EU Regulation 536 There is a one-year transition period, during which your organization can choose to use either the old procedures or the new procedures when launching clinical trials. Note, however, that if your trial is still ongoing after January 31, 2025, you will have to transition to the new system to continue it. As a result, we urge you to get compliant with the new standards as soon as possible. Here are five strategies we recommend for a successful transition: Be ready to manage Clinical Trial Application processes using the CTIS portal. Double-check your standard operating procedures for compliance. Ensure that your clinical trial supplies comply with new Investigational Medicinal Product (IMP) labeling requirements. Be ready to comply with public disclosure guidelines and Requests for Information. Above all: Centralize, centralize, centralize! Take advantage of the new, streamlined processes to streamline your own workflows. And remember, the new regulation requires shorter timelines for validation, assessment and approval. Regulators have new deadlines to meet…but so do sponsors. And these are timelines with teeth. If you don’t meet the deadlines on your end, your application will be rejected and you’ll have to resubmit. How ULG Can Help In many respects, the new regulations are a welcome change. However, they will also require sponsors and CROs to adjust to a new way of doing things to remain competitive and compliant. At ULG, we’re here to help. Here’s how. Centralized Language Services We’re a one-stop shop, enabling centralization. Even if you’re working individually across various teams, divisions, products, and countries, ULG houses all activity and data enterprise-wide for optimal consistency and transparency. Expertise ULG has long been a leader in translation and localization in the Clinical space. We are proven experts in this field and can help you reach compliance. Tools, Tech and Processes Via our Octave™ technology suite, we centralize all translation assets and data to ensure maximum leverage and enhanced visibility. Additionally, if you have questions about language requirements under the new EU regulation or need recommendations on optimizing your translation, don’t hesitate to contact us. Our expert team is here to help!
终于,欧盟(EU)临床试验信息系统(CTIS)已经准备就绪。这意味着欧盟第536号条例将于2022年1月31日生效。尽管赞助商进行新的临床试验有一年的过渡期,但有远见的公司应该尽快满足新的要求。在联合语言集团,我们将帮助您应对复杂的监管环境,并在合规过程中的每一步为您提供支持。 什么是欧盟第536号法规?简要总结 欧盟法规第536号要求临床试验发起人和合同研究组织(cro)使用新的集中门户和数据库提交临床试验信息。这项规定于2014年颁布,原计划于2015年推出;然而,该门户网站的延迟推出意味着它将于2022年1月31日生效。 目标:一个集中审查的过程 有时候,改变是好的。例如,该法规简化了程序,更好地利用现有和“本地”数据,并有望使在欧盟进行临床试验变得更容易。临床试验申请、规则和审查时间将得到协调,最终使赞助商和cro更容易管理过程并保持合规。 然而,临床试验的某些方面仍将受到国家法律管辖,具体取决于所涉及的国家。例如,每个成员国可能有自己的语言要求,以及自己的有关费用、生物样本、转基因生物、数据保护和放射程序的法律。 关注透明度和公众可及性 透明度是新规的另一个重要方面。您的大多数临床试验信息和数据需要通过数据库向欧盟的每个人公开访问。此外,在试验结束之日起的一年内,必须提供该研究所在国家的官方语言的简明语言摘要(PLS)。PLS是一份书面的和呈现的试验信息的摘要,这样外行就可以很容易地理解它。根据欧盟条例536,这些不再是简单的“拥有很好”。现在,它们是合规的必要条件。 所有这些都可能意味着需要额外的翻译,超出您目前提供的翻译。ULG在这里帮助你导航。 成功实施欧盟536条例的建议策略 有一年的过渡期,在此期间,你的组织在启动临床试验时可以选择使用旧程序或新程序。但是请注意,如果您的试验在2025年1月31日之后仍在进行,您将必须过渡到新系统以继续试验。因此,我们敦促您尽快遵守新标准。 以下是我们推荐的成功转型的5个策略: 准备好使用CTIS门户网站管理临床试验申请流程。 仔细检查你的标准操作程序是否符合要求。 确保您的临床试验用品符合新的临床试验药品(IMP)标签要求。 准备好遵守公开披露准则和信息要求。 最重要的是:集中,集中,集中!利用新的、简化的流程来简化您自己的工作流程。请记住,新规定要求缩短验证、评估和批准的时间。监管机构有了新的期限,但赞助商也是如此。这些是有牙齿的时间线。如果你没有在最后期限前提交,你的申请将被拒绝,你必须重新提交。 ULG如何提供帮助 在许多方面,新规定都是一个可喜的变化。然而,他们也将要求赞助商和cro适应一种新的做事方式,以保持竞争力和合规。在ULG,我们随时为您提供帮助。这是如何。 集中语言服务 我们提供一站式服务,实现中心化。即使您是跨不同的团队、部门、产品和国家单独工作,ULG也会在企业范围内保存所有活动和数据,以实现最佳的一致性和透明度。 专业知识 ULG长期以来一直是临床领域翻译和本地化的领导者。我们是这一领域的专家,可以帮助你实现合规。 工具、技术和流程 通过我们的Octave™技术套件,我们将所有的翻译资产和数据都集中起来,以确保最大限度地发挥作用并增强可见性。 此外,如果您对欧盟新规定下的语言要求有疑问,或需要优化翻译的建议,请立即与我们联系。我们的专家团队在这里为您提供帮助!

以上中文文本为机器翻译,存在不同程度偏差和错误,请理解并参考英文原文阅读。

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