When submitting a DMF or API registration application, if the specification of the drug substance is established based requirements listed in a compendial monograph, what should other requirements be noted?

刊登日期:2020-07-22  |  點閱次數 : 1234 次 
  1. 1. According to “Regulations for Registration of Medicinal Products”, if the specification of a drug substance is established based on a compendial monograph, the title, year of publication, edition number, and page numbers of the pharmacopeia should be indicated. Only Chinese Pharmacopeia and pharmacopeias published by the ten medically advanced countries, or pharmacopeias approved by the central health competent authority (i.e., European Pharmacopeia) are acceptable. The pharmacopoeia should have been published within the last 5 years. If the relevant content of above pharmacopeia has major revision within the last 5 years, it is recommended to revise the drug substance specification based on the latest version of the pharmacopoeia. Other pharmacopoeias, such as the International Pharmacopoeia published by WHO, will be accepted on a case-by-case basis.
  2. 2. If a DMF application is an applied for abbreviated review/verification based on Certificate of Suitability (CEP), the drug substance specification must be established based on the latest edition of the European Pharmacopoeia.


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