Medicine data: paediatric investigation plans (PIP)

Information on opinions and decisions adopted by the European Medicines Agency's (EMA) Paediatric Committee (PDCO) on Paediatric Investigation Plans (PIPs) including deferrals and waivers. A PIP is a medicine development plan aimed at ensuring the necessary data are obtained through studies in children to support the medicine's authorisation for use in children. The plan is submitted by a pharmaceutical company to the PDCO, which is responsible for agreeing or refusing the plan and for publishing an opinion with its decision. Search results can be exported in Excel format.本数据集收录欧洲药品管理局（European Medicines Agency, EMA）儿科委员会（Paediatric Committee, PDCO）针对儿科研究计划（Paediatric Investigation Plans, PIPs）所作出的意见与决议相关信息，其中涵盖推迟审评与豁免申请两类情形。 儿科研究计划是为确保通过儿童相关研究获取必要数据，以支撑该药品在儿童人群中的使用获批而制定的药物研发计划。该计划由制药企业提交至PDCO，由该委员会负责对计划进行审核并作出同意或否决的决议，同时发布附带其决议的审评意见。 搜索结果可导出为Excel格式。