本文件旨在为从人或动物 (即哺乳动物、鸟类、昆虫等)的特定细胞系制备的生物技术产品提供病毒安全性的测试和评价方法，并提出了上市注册时应提交的一套资料。 本文件所述病毒不包括非常规性传播因子，如与疯牛病 (BSE)和瘙痒病 (scrapie)有关的传播因子。 有关疯牛病的问题，申请人应与管理部门进行讨论。 本文件的范围涉及从特定细胞库引入的细胞培养物中所提取的产品，既包括从体外细胞培养物所提取的产品，如干扰素、单克隆抗体和重组DNA产品 (包括重组亚单位疫 …

The Q3C ICH Guideline was finalised under Step 4 in July 1997, providing recommendations on the use of less toxic solvents in the manufacture of drug substances and dosage forms, and setting pharmaceutical limits for residual solvents (organic volatile impurities) in drug products. Maintenance Process

ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity. A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years.

The Map of e-Inventories of Intangible Cultural Heritage enables direct access to 213 e-Inventories. The Map is searchable by geo-referencing, word, country, inventory name; UNESCO electoral group; format; geographical level; organization; ICH domains and multimedia resources.

The ICH Association comprises the following Members and Observers: Standing Observers. Legislative or Administrative Authorities. Regional Harmonisation Initiatives (RHIs) International Pharmaceutical Industry Organisation. International Organisation regulated or affected by …

ICH指导原则由国家药品监督管理局药品审评中心发布，提供药品研发和审评的指导。

Check out ich's vast resource locations now. As a rite of passage, lễ cấp sắc (literally means conferring a certificate of approval) marks the initiation of a Red Yao man into his spiritual maturity and religious efficacy. Filmed in a village of the Red Yao people, which is located in the mountainous area of Lào Cai province, 260 km north.

2023年12月13日 · The International Council for Harmonisation (ICH) has established four distinct stability zones to guide pharmaceutical stability storage and testing of products. These zones represent different climatic conditions worldwide to ensure that pharmaceutical companies test products under environmental conditions similar to where they will be stored ...

condition for Climatic Zone III/IV countries in ICH Q1F. The document was adopted by the ICH Steering Committee in February 2003 and subsequently implemented in the ICH regions.

2024年6月3日 · 为了与国际药品监管标准接轨，中国药品监督管理局（nmpa）自国际人用药品注册技术协调会（ich）成立以来，始终与其保持紧密合作，致力于将ich的指导原则在国内落地实施。