No. Class Title
  41   Drug Substance  

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?

  42   Drug Substance  

If an active pharmaceutical ingredient (API) has an amorphous crystal form, is it necessary to provide analysis results for its crystal form?

  43   Drug Substance  

If a drug substance is not included in monographing pharmacopeia, what are the requirements for the drug substance specification?

  44   Drug Substance  

According to the DMF technical information check list promulgated by TFDA, the drug substance process validation data may be replaced by the process validation protocol and a representative batch record. Is it required for the representative batch record to be from one of the process validation batches?

  45   Drug Substance  

Is it required to submit separate DMFs for the same drug substance but with different grades of particle sizes (different particle size distributions) ?

  46   Drug Substance  

If the submitting drug substance with two or more crystalline hydrate formulas, should DMF divide into different applications? If a drug substance has different solvated forms (hydrates), is it required to file a separate DMF for each of the hydrate?

  47   Drug Substance  

What types of administrative documents should be authenticated by R.O.C. (Taiwan) Foreign Affairs Offices for the application of an imported API registration?

  48   Drug Substance  

Should GMP certificates be required for the registration of an API?

  49   Drug Substance  

For active pharmaceutical ingredients or active pharmaceutical ingredients of drug products with licenses, shall the changes of technical documents be submitted to the TFDA?

  50   Drug Substance  

How long does it take for the DMF review? If the documentation is insufficient, what is the procedure for the submission of the supplement?

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