MHRA第三国GMP检查 Workshop on GMP/Pharmacopoeia/APIs
The IRP integrates and simplifies both the Mutual Recognition/Decentralised Reliance Procedure and the ECDRP under one streamlined process.1,2 A Breakthrough Case Study A new formulation of a pre-filled syringe denosumab at 120 mg (Xgeva, Amgen) for the treatment of bone cell degeneration due ...
Importing investigational medicinal products into Great Britain from approved countrieshttps://www.gov.uk/government/publications/importing-investigational-medicinal-products-into-great-britain-from-approved-countries List of approved countries for authorised human medicineshttps://www.gov.uk/government/publicatio...
英国脱欧后,英国的临床试验法规与欧盟成员国的法规不同。因此,英国药品和保健产品监管局(MHRA)今年初在其博客上发表了一篇关于研究性药品(IMP)制造的文章。这适用于所有希望在英国的研究者地点进行临床试验或在英国进行任何IMP制造活动的人。 本Q&A与以下主题有关: 制造/复溶 许可/测试 稳定性/有效期期 QP和包装/...