歐洲藥品管理局（EMA）于2018年11月發(fā)布了"制藥用水質(zhì)量指導(dǎo)原則（草案）"，詳細(xì)介紹了在人用、獸用制劑和原料藥生產(chǎn)時(shí)，不同情況下注射用水的選擇。介紹EMA該文件中對不同用途的水質(zhì)要求，并與國內(nèi)的相關(guān)要求進(jìn)行對比，期望引起有關(guān)各方關(guān)注和思考，保障我國制藥用水的質(zhì)量，進(jìn)而保證藥品質(zhì)量，保護(hù)用藥者安全。

European Medicines Agency (EMA) issued the "Guideline on the quality of water for pharmaceutical use (Draft)" in November 2018. This guideline is intended to provide guidance on the pharmaceutical use of different grades of water in the manufacture of active substances and medicinal products for human and veterinary. This paper describes the quality requirements in detail for different uses of pharmaceutical water in the guideline and compares them with the relevant domestic requirements. It is hoped that all parties concerned will pay attention to and think about it to ensure the quality of pharmaceutical water used in China, thereby ensuring the quality of drugs and protecting the safety of drug users.