EMA GMP问答增加 8.反渗透法制备的注射用水(WFI)(03.31)
EMA Questions and answers: Good manufacturing practice
无菌附录增加 8. Water for injection by reverse osmosis 反渗透法制备的注射用水(WFI)
EMA复方制剂的临床开发(03.31)
Clinical development of fixed combination medicinal products
EMA 吸入制剂和鼻用制剂药品质量指导原则修订的概念文件(03.23)
Concept paper on revision of the guideline on the pharmaceutical quality of inhalation and nasal products
EMA 口服吸入产品的临床文献要求,包括证明两个吸入制剂的治疗等效性,用于成人哮喘、肺慢性阻塞性疾病(COPD)的治疗和儿童、青年哮喘的治疗;该指导原则修订概念文件(03.23)
Concept paper on revision of the guideline on the requirements for clinical documentation for orally inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for use in the treatment of asthma and chronic obstructive pulmonary disease (COPD) in adults and for the treatment of asthma in children and adolescents
FDA 移植肾功能延迟的预防药物指南草案(03.23)
Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention