FAQ
Drugs

What information on the reference standards or materials is required for the registration of generic drugs?

刊登日期:2019-11-13  |  點閱次數 : 1729 次 

The information on the reference standards or materials recommended for the registration of generic drugs is listed as follows:

  1. 1. The reference standards for tests should be indicated whether they are primary standard or working standard. For primary standard, the source should be specified. For working standard, the source, batch number, labelled content (or potency), testing specifications, certificate of analysis and calibration procedures should be specified.
  2. 2. If a compendial primary standard is used, in addition to the CoA of the primary standard, it is recommended providing the proof of purchase, such as receipts or photographs of the primary standard indicating the lot number.
  3. 3. If the primary standard is provided by the manufacturer of the drug substance, the spectrometric spectra (e.g., IR, NMR, and MS, etc.) and its structure elucidation should be provided to support the reliability of the primary standard. If the drug substance provided by the manufacturer of the drug substance is used as a working standard, the relevant information of the primary standard that is used to qualified the working standard by the manufacturer of the drug substance should be submitted.

(中文版)


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