EMA Finds Scientific Advice Leads to Stronger Trial Design
提交事前咨询请求: 针对FDA,您可以通过Pre-Submission(事前咨询)程序向FDA提交请求,而EMA可以通过Scientific Advice(科学建议)程序提供咨询。 3. 制定和提交申请: 制定全面的申请: 根据监管机构的要求,制定全面的申请文件,确保包括所有必要的信息和支持文件。 制定临床试验计划: 如果您的研究涉及临床试验,确保制定完整...
在计划阶段与监管机构进行初步沟通,以获取关于试验设计和提交要求的反馈。 提交初步研究计划(Protocol Assistance,FDA)或药物开发咨询(Scientific Advice,EMA)申请,以获取监管机构的意见。 申请准备: 制定完整的研究计划,包括研究设计、试验流程、数据收集和分析计划等。 编写适当的文档,包括研究方案、病例报告表(Case Repo...
The general guidance should be used to develop product-specific protocols to demonstrate equivalence, facilitated by obtaining scientific advice, as necessary. 关于安全性和局部耐受性的等效性可以从活性物质的知识和已完善的辅料的选择中推断岀来。针对简单配方,从渗透动力学或药效等效性研究中可获得生物等效豁免...
Commentsshouldbeprovidedusingthistemplate.Thecompletedcommentsformshouldbesentto EWPSecretariat@ema.europa.eu 11 KeywordsInteraction,guideline,metabolism,inhibition,induction,transport,absorption, food,distribution,herbal,SmPC,SPC 12 2/38 GuidelineontheInvestigationofDrugInteractions13 14 15 16 17 18 19 20 ...
restrictionofamarketingorextensionauthorisationorapplication(insideoroutsideEEA)11A.4Regulatoryadviceonthedevelopmentoftheproduct11PartB-Overalldevelopmentofthemedicinalproductincludinginformationonthetargetdiseases/conditions13B.1.Discussiononsimilaritiesanddifferencesandpharmacologicalrationale13B.1.1Similaritiesanddifferencesof...
Follow your HCP's advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen. Increased risk of major cardi...
Scientific Advice Strategy: Working with EMA and FDA
As medicines development continues towards a globalized approach, both the pharmaceutical industry and regulatory agencies increasingly seek opportunities to proactively engage early in product development. The parallel scientific advice program shared by the European Medicines Agency (EMA) and the US Food ...
EMA publishes parallel scientific adviceThe article reports on the European Medicines Agency's publication of its parallel scientific advice on drug development from health technology assessment organizations and regulators.doi:10.1038/nrd4358NoneNature Reviews Drug Discovery...