Overview:
CADIFA (letter of suitability of the active pharmaceutical ingredient) is the administrative instrument that attests the compliance of a DIFA (active pharmaceutical ingredient dossier) with the requirements of Resolution – RDC nº 359/2020. It attests that the quality of the API (Active pharmaceutical ingredient) is suitably controlled by the tests that comprise its specification. A CADIFA does not replace a certificate of analysis, nor does it ensure that a batch of the API is of suitable quality.
Introduction:
A valid CADIFA and GMP certificate are necessary for the approval of an associated marketing authorization or post-approval change application. The Brazilian marketing authorization holder (MAH) is responsible for the API quality used in the manufacture of the drug product.
Although the manufacturer must ensure that the API is produced according to Good Manufacturing Practice (GMP) requirements, the assessment of a CADIFA application does not have the purpose of verifying GMP compliance. Therefore, a CADIFA is neither equivalent to a GMP certificate nor does it replace it.
To obtain a CADIFA, a DIFA must be submitted to Anvisa by the DIFA holder. A CADIFA application must be submitted previous to and be associated to a marketing authorization or post-approval change application. A time limit was not established for how much time in advance the CADIFA application must be submitted.
Have an associated CADIFA, the DIFA holder must provide:
- A letter to the MAH, with the DIFA’s Reference Number, authorizing the use of the DIFA as part of marketing authorization or post approval change application.
- Copy of the CADIFA with the declaration access filled on behalf of the MAH by DIFA.
- Holder, when a CADIFA has already been issued for that API. In turn, the MAH must inform Anvisa in the drug product marketing authorization or post approval change application the DIFA Reference Number through the submission of the “CADIFA Process Notification” codes 11721 (registration) and 11722 (post approval change).
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