Sinclair 3106 6° 4 - CABA

Approving Provisions issued by ANMAT – 2018

The summary of the approving provisions issued by ANMAT in 2018 shows that:

• The number of clinical trials admitted to ANMAT / DERM in the second semester of 2018
increased by more than 40% compared to the first semester. There were 61 trials admitted in
the first semester compared to the 103 in the one.

• The number of authorizations of EFCA 1 in the DERM, clinical trials area, was more than
double (55%) in the second semester in relation to the first: there were 38 authorizations in
the first half of the year and 85 authorizations in the second half of the year, maintaining in
general, the same number of authorizing provisions issued by ANMAT per semester.

• All this was done with two evaluators less.

• The evaluation timeline was stable and competitive due to the maximization of the
performance and efforts of the evaluators.

• A greater number of study admissions, EFCA 1, implies a greater number of EFCA 2
(increase/decrease of clinical trials centers), EFCA3 (amendments), EFCA4 (Product Monograph
Update), communications to DERM and extensions of import/export of materials. ALL these
tasks are performed by clinical trial evaluators. The work capacity is at its maximum.


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