链接:https://www.biopharminternational.com/view/ema-to-improve-drug-approval-process
1. EMA. Improving Efficiency of Approval Process for New Medicines in the EU. Press Release. Oct. 2, 2024. 链接:https://www.biopharminternational.com/view/ema-to-improve-drug-approval-process
Some of these challenges are elucidated by the drug approval process of the EMA that tries to incorporate all member nations of the E.U under one regulatory agency. This is a theme that will continue to emerge as we look at world in which information and medicine become intertwined....
https://www.euractiv.com/section/coronavirus/news/eu-drug-agency-covid-vaccine-side-effects-still-being-monitored/ <dc:creator> <![CDATA[ Marta Iraola ]]> </dc:creator> <pubDate>Tue, 28 Mar 2023 17:27:02 +0000</pubDate> <category> <![CDATA[ anti-vaxxers ]]> </category> <category...
Definitions 定义 Control Strategy: 控制策略 A planned set of controls, derived from current product and process understan ding that ensures process performance and product quality. The controls can i nclude parameters and attributes related to drug substance and drug product materials and components, ...
EMA 原料药和相关成品的稳定性指南 2003.12.17-英文.pdf,European Medicines Agency Inspections London, 17 December 2003 CPMP/QWP/ 122/02, rev 1 corr COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) GUIDELINE ON STABILITY TESTING: STABILITY TESTING OF EXIS
of the world, it must get permission first from the EMA. If the EMA grants approval, the drug can be used throughout the European Union, Iceland, Norway, and Liechtenstein. The EMA also monitors the safety of medicines after they have been approved, through a process called pharmacovigilance...
同样,合成路线很长并不能弥补很差的控制策略5.1.2 Selection of starting materials for semi-synthetic drug substances半合成原料药的起始物料的选择在本指南中,半合成原料药是指原料药结构是由一部分化学合成结构和生物来源结构(例如,发酵、植物原料提取)合并而成。在有些情况下,申报人可以从来源物料(微生物或植物...
1. Manufacturing steps that impact the impurity profile of the drug substance should normally be included in the manufacturing process described in Section 3.2.S.2.2 of the application. 对原料药杂质谱有影响的生产步骤一般要包括在申报资料3.2.S.2.2部分生产工艺描述中。
Drug Approvals and Databases 药品批准情况和数据库✦ 3 Drug Development and Review Process 药品申报和审评流程✦ 4 Guidance, Compliance, and Regulatory Information 指南、合规性和监管信息 5 Regulatory Science and Research 科学与研究...