2）Medicine type药品类型搜索，包括：Accelerated assessment加速审评（可查询共112个药品的加速审评情况）、Additional monitoring附加监测（共766个药品需要完善相关信息）、Biosimilar生物仿制药（共101个药品）、Conditional approval有条件批准（共125种药品）、Exceptional circumstances特殊情况、Generic仿制药（共355中药品...
EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline. An opinion ...
BRUSSELS, Feb. 24 (Xinhua) -- The European Medicines Agency (EMA) on Friday recommended approving a conditional marketing authorisation for Natpar, a medicine used to treat hypoparathyroidism, in the European Union (EU). Hypoparathyroidism is a hormone disorder where the parathyroid glands in th...
统计发现,2016年,7个新药通过加速审评通道上市(该加速审评时限为150天,而标准审评时限是210天)。8个新药通过“有条件批准(conditional marketing authorisation)”通道上市,即批准时依据的临床资料尚不完整,上市后的药品应继续获取完整临床数据。 欧盟的孤儿药认定申请数量也在不断增加。 其中,EMA的孤儿药认定申请在2...
第三部分:Marketing authorisation上市许可,欧洲药品管理局(EMA)负责对集中上市许可申请(MAA)进行科学评估。一旦被欧盟委员会批准,集中上市许可在所有欧盟(EU)成员国、冰岛、挪威和列支敦士登有效。包括:Obtaining an EU marketing authorisation获得欧盟的上市许可, The evaluation of medicines step-by-step逐步获得欧盟市场...
第三部分:Marketing authorisation上市许可,欧洲药品管理局(EMA)负责对集中上市许可申请(MAA)进行科学评估。一旦被欧盟委员会批准,集中上市许可在所有欧盟(EU)成员国、冰岛、挪威和列支敦士登有效。包括:Obtaining an EU marketing authorisation获得欧盟的上市许可, The evaluation of medicines step-by-step逐步获得欧盟市场...
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation for Janssen’s Talvey (talquetamab). The drug has received a positive opinion for use as a monotherapy for the treatment of adult patients with rela...
图1：FDA新药获得特别审批通道比例 目前，欧盟的新药加快审评审批政策中，也有4种加快审评的特殊途径，分别是有条件批准（Conditional marketing authorisation）、特例批准（Approval under exceptional circumstances）、加速审评（Accelerated assessment）、优先药物（PRIME）。加速审评能够让新药在上市注册申请阶段缩短审评...
NEW BRUNSWICK, N.J., February 16, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen-Cilag International N.V., has submitted a conditional Marketing Authorisation Application (cMAA) to the European Medicines Agency (EMA) seeking authoris...
目前,欧盟的新药加快审评审批政策中,也有4种加快审评的特殊途径,分别是有条件批准(Conditional marketing authorisation)、特例批准(Approval under exceptional circumstances)、加速审评(Accelerated assessment)、优先药物(PRIME)。加速审评能够让新药在上市注册申请阶段缩短审评时间,审评时间由原来的210天变为150天。优先...