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...
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...
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...
(Generic medicinal product application)、改良申请(Hybrid application)、生物类似药申请(Similar biological medicinal products application)、良好应用药品申请(Well-established medicinal use application)、固有复方制剂申请(Fixed combination medicinal products application)和知情授权申请(Informed consent application)6种...
preparations for auricular or ocularuse. Specific guidance isprovided: 本指南适用于应用于局部皮肤并发挥局部作用药物,也适用于其他药物,例如眼用药物与耳用药物。具体内容包括:On the quality of topical products not covered by otherguidelines. 其他指南未涵盖的外用制剂的质量。 On equivalence testing of ...
In recent years, some relevant regulations and guidelines have been issued. This paper introduces in detail the requirements of EMA for pediatric information in SmPC, and looks forward to arousing the attention of our country. It is suggested that the drug marketing license holders in China refer...
193.Legalbasisandrelevantguidelines4 204.Activesubstance4 214.1.GeneralInformation3.2.S.14 224.1.1.Nomenclature3.2.S.1.14 234.1.2.Structure3.2.S.1.24 244.1.3.GeneralProperties3.2.S.1.35 254.2.Manufacture3.2.S.25 264.2.1.Manufacturer(s)3.2.S.2.15 ...
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 ...
European guidelinesScientific advicesHematologyOncologyMarketing authorisationMédicament biologique similaireBiosimilaireFor the past ten years, innovative biological products have had an important impact in treating life-threatening and chronic diseases such as cancer. With the expiry of patent rights and ...
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] ...