National Institute of Metrology, Quality and Technology-INMETRO proposed Resolution establishes the rules for conducting clinical trials with product of advanced investigational therapy in Brazil and gives other measures.

This Resolution applies to clinical trials with product of advanced investigational therapy, which will be developed in Brazil, for safety verification, efficacy or efficacy and safety purposes.

Registration and post-registration of products of advanced therapy should follow specific regulations.

This Resolution does not apply to:

• Clinical trials with medicaments regarding RDC 9, 20 February 2015 or its updates; and
• Clinical trials with medical devices regarding RDC 10, 20 February 2015 or its updates

This Resolution also establishes the responsibilities of sponsor and research-sponsor and general requirements for submission to Anvisa.

Products covered:Advanced investigational therapy

HS code: 90

Proposed date of adoption:NA

Proposed date of entry into force:NA

Final date for comments: NA

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