DMF备案 Drug Master Files (DMF)



DMF 药物管理档案(Drug Master Files, DMF)是一份提交给美国FDA的保密文件,它提供了关于用于生产药物的原料、活性中间体及其设施、流程、包装及仓储等相关的信息。

Drug Master Files (DMF)

Drug companies can file a Drug Master File (DMF) in eCTD format to FDA, in order to keep their processing, material and facility confidential to the public. With the submission of DMF, the drug companies can authorize others to reference this DMF to support others' New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) without disclosing any information related to Intellectual property. RGLM consulting is proud to assist customers to prepare and submit DMF to FDA.