February 2018: Brazil Regulatory Updates

In March 2017, the Brazilian Senate approved the PLS 200 law, after three years of debate. The law still needs approval from the Brazilian parliament before it can be implemented, but it aims to speed up the approvals process by removing bureaucracy from the analysis and registration of new drugs.13

PLS 200 optimises the regulatory framework and expedites regulatory approvals. It creates an accreditation process for research ethics committees under the national research ethics committee (CONEP), coordinated by the Secretariat for Science, Technology and Strategic Inputs (SCTIE), of the Brazilian Ministry of Health. It also creates a procedure for analysing study protocols for risk, standardising and setting deadlines. Protocols which have minimum-to-low risk can be fast-tracked, while medium-to-high risk protocols will proceed to the Ethics Committee approval process.14

The new law guarantees access to the experimental drug, post-study, if it proves to be beneficial and indispensable for the patient’s continued treatment after the end of the trial. It also contains provisions to protect the health of the patient by guaranteeing medical assistance by qualified personnel throughout the study.

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