This is a common question that I answer, mainly because we have already evaluated dozens of international dossiers, and I have observed is that the adequacy points are always the same:
· Analytical Validation: RDC 166/17 X ICHQ2
· Forced degradation study (RDC 53/2015XICH Q1 A and B, Q2B, Q3A and B,)
· Development of the Dissolution Method (RDC 31/2015)
· Some points from the Stability and Photostability Study (RDC 318/2019 x Q1 A, B and C)
The next question is: if ANVISA is a member of the ICH, then why do the requirements differ?
The divergences are not that great and, to a certain extent, the requirements are aligned with each other. The point is that the ICH provides general guidelines to be followed, meanwhile ANVISA requires details, therefore, international documents and tests often need adjustments to meet Brazilian regulations.
Drawing a parallel, it is like comparing the US constitution with the Brazilian one. The North American describes the general principles to be followed and, therefore, is basically the same since 1787.
The Brazilian constitution, on the other hand, describes the details and often needs to be updated. We are already in the 8th edition and, even the current one, has already undergone several changes.
It should be noted that after joining the ICH, ANVISA is much more flexible in discussing and accepting tests based on international guidelines, but analytical validation and forced degradation studies are still important points.
ICH is currently discussing the Q2(R2)-VALIDATION OF ANALYTICAL PROCEDURES and Q14-ANALYTICAL PROCEDURE DEVELOPMENT guides and, once finalized, these critical points tend to be less questioned in the registration processes in Brazil.
Regardless of the changes that may come, companies that work with international dossiers must have the expertise to carry out a good gap-analysis to capture the differences and be able to assess whether they are within ANVISA's acceptance limit.
To conclude, before deciding on whether to perform pre-submission compliance, consideration should be given to the time needed to adjust the requirements if a requirement is received.
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