European guidelinesScientific advicesHematologyOncologyMarketing authorisationMédicament biologique similaireBiosimilaireFor the past ten years, innovative biological products have had an important impact in t
This 'hybrid approach' is in line with the other new European process validation guidelines, too. 工艺验证以生命周期形式提出,与附录15和EMA制剂工艺验证指南具有可比性。指南还提供了传统的和加强的工艺验证方法(参照ICH Q11),也与上述两指南具有可比性。两种方法的联合也是可能的。这种“混合方法”也与其它...
例如,依次点击上述的 Good manufacturing practice(GMP)→Legal framework and guidance→EU GMP guidelines,可获取EMA关于GMP的具体指南内容(网址:https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en): 3.2.2 Research and development 研究与开发 为药品的开发和设计提供指导,如临床试验...
EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines; European Pharmacopoeia general chapter 5.1.5 ‘Application of the F0 concept to steam sterilisation of aqueous preparations’; European Pharmacopoeia general chapter 5.1.2 ‘Biological indicators and related microbial preparations used in t...
NMPA. Technical guidelines for extrapolating adult drug use data to pediatric population [EB/OL]. (2017-05-18) [2022-07-17]. https://www. nmpa. gov. cn/directory/web/ nmpa/xxgk/ggtg/qtggtg/ 20170518163201802.html. [责任编辑 李红珠] ...
3.2.5 Herbal products 草药制品 在该模块包括与草药申请相关的内容,如:Regulatory and scientific support法规和科学支持信息,用于向HMPC寻求帮助;Scientific guidelines科学指南(质量、非临床、临床和安全方面)、Q&A: Herbal medicines草药上市申请常见问答信息、Procedures程序等。 3.3 Veterinary regulatory 兽药制品 兽药制...
2023 年5 月,FDA 多个中心联合发布《人工智能和机器学习用于药品与生物制品开发的讨论文件》(Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products :Discussion Paper and Request for Feedba...
2023 年5 月,FDA 多个中心联合发布《人工智能和机器学习用于药品与生物制品开发的讨论文件》(Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products :Discussion Paper and Request for Feedback), 就在药品、医疗器械(包括药械组合产品)开发中运用AI/ML 向利益攸关方征询...
From the starting materials to the finished products, complex mixtures of active ingredients are unknown. At present, China has not yet formulated relevant guidelines for the quality standards of traditional Chinese medicine or Chinese herbal medicines (decoction pieces). Introduce the main contents of...
Directive 2001/83/EC of the European Parliament and of the Council of 6 N ovember 2001 on the Community code relating to medicinal products for hum an use; 3. Eudralex volume 4 (GMP guidelines); 4. Guideline on process validation for finished products - information and data to be ...