FAQ
Drugs

What are the requirements of official documents to authenticate the drug substance that has been approved by regulatory agencies in an abbreviated review for a DMF application?

刊登日期:2020-07-22  |  點閱次數 : 1254 次 

These official documents include CEP、CPP、FSC、EIR and GMP Certificate. (CEP is valid for five years from the issuance date, which should be a currently approved version on the website of EDQM. The other types of documents are valid for two years.)

  1. 1. It must be able to authenticate the drug substance that has been approved by regulatory agencies or used in marketed medicinal products. Besides the name of a drug substance, it must contain the name of manufacturer and the address of manufacturing site.
  2. 2. The original or a copy of the document with authentication should be provided. All the information on the copy should be complied with the “Regulations for Registration of Medicinal Products” and be declared that the copy is identical to the original one. If necessary, upon the request of the TFDA, the applicant should provide the original copy of the document.
  3. 3. The authentication requirement is waived for the copy of the CEP issued by the EDQM. However, the information on the CEP copy should be valid. If necessary, upon the request of the TFDA, the applicant should provide the original copy of the document.

(中文版)


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