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Publication of the Public Consultation for the review of RDC 200 - what is new?




Last week, the long-awaited Public Consultation for the review of RDC 200 was published, which opens new horizons for incremental innovation in Brazil. Check out the news:

Introduces the concept of registration routes; where the registration classification will not be based on the type of innovation as a new pharmaceutical form or new concentration; but because of the type of scientific basis that innovation requires:

· Complete Development Pathway that requires complete clinical development and without altering what is currently undergoing the concession of a new molecule.

· Via the registration of generics and the like with proof of safety and efficacy through Pharmaceutical equivalence and Bioequivalence.

· Abbreviated Development Pathway, which is the big news, where the proof of safety and effectiveness would be based partially on data from existing products and on studies generated by the applicant, which will correlate the proposed drug with the comparator drug.

The abbreviated development path will bring a significant gain to innovation in Brazil, as it does not fix a list of evidence to be presented and the company will have the freedom and responsibility to choose how to prove safety and effectiveness, which may vary from scientific literature, bridge study, non-clinical and clinical studies. But as everything has two sides, it will be up to the requesting company to base and justify technically and scientifically the rationality of the proposed development.

I invite everyone to read and contribute to the public consultation of this long-awaited regulatory framework for incremental innovation at the link:

https://sindusfarma.org.br/uploads/file%20-%20Copy%20112.pdf