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Outcome of the RDC 200 Review Working Group meeting - 02/05/20

Yesterday, 02/05/20, was the penultimate chapter of the WG that is discussing the new rules for drug innovation where there was a sincere discussion about the possibility of the clinical research and registration areas to previously evaluate the clinical development plan for new and innovative drugs, and although ANVISA liked the proposal presented by the regulatory sector, they made it clear that with the current number of technicians this is not feasible. The proposal was:

· Possibility and filing the clinical development proposal Evaluation by COPEC and COINC or GESEF

· Meeting to discuss the proposal ANVISA's official statement on the proposal.

On the other hand, it stated that it is working internally to formalize the analysis flow of the DDCM (Clinical Drug Development Dossier) where COPEC (Clinical Research Coordination) forwards the study protocol to COINC (Coordination of Incremental Innovation)(s) clinician(s) to ensure that afterwards the positive result of the study is adequate to register the drug.

A proposal accepted by ANVISA to be inserted in the CP is that the development plan approved prior to the registration request must be respected by both the applicant and Anvisa.

However, the definition of an innovative drug has not reached consensus since other discussions involving pricing are taking place. The text reached was: medicine with incremental innovation, which demonstrates a clinical or technological advantage over medicines already registered in the country, including new salts, isomers or a mixture of isomers, esters or ethers.

Considering that it is a heterogeneous group and, within the possible game, proposals were reached that were accepted by all parties.

Class entities will publish the full text harmonized by the WG and a public consultation will soon be published where everyone will be able to participate and improve the text that was worked on by the WG.

On the next meeting on February 19, the closing report and other secondary activities will be prepared.

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