What are the requirements for filing a DMF or API application where the drug substance is a mixture of two other drug substances?

刊登日期:2020-07-22  |  點閱次數 : 699 次 
  1. 1. For applications involving mixing of two drug substances, only those for which the drug substance mixture composition and mixing ratio being published in monographs of Chinese Pharmacopoeia or Pharmacopoeia of Ten Medically Advanced Countries are considered acceptable. Otherwise, evidences showing the drug substance mixture meets unmet medical needs and possesses major clinical advantages must be provided.
  2. 2. Complete CTD Module 3 data (open part + closed part) should be provided for each drug substance component of the drug substance mixture.
  3. 3. In addition, it is suggested that the applicant obtained DMF or API approval for each separate drug substance before submit the DMF or API application for the drug substance mixture.


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