Regularização de Produtos - Bioequivalência e Biodisponibilidade

Biovailability / Bioequivalence

The International CROs that intend to be certificated by Anvisa, must contact a national company to represent them at ANVISA.

The selected national company will be responsible for the submission of specific application forms for first certification or certification renewal.

It is recommended that the application form for certification renewal be submitted at least 180 days before the expire date.

All necessary guidelines, documents and application forms are available below.

Application Forms

Certification for Medicine Bioavailability/Bioequivalence Centers (word)

Regulation:

Inspection Guideline

RDC nº 56/2014
The Centers that carry out Bioavailability/Bioequivalence studies for the purpose of medicine registration shall observe the rules and technical regulations in force.

Bioavailability / Bioequivalence Report
This report must be filled in by the CRO for each study performed, informing the status of each phase. The reports filled in must be sent to Anvisa (by mail: equivalencia.terapeutica@anvisa.gov.br) every three months (4 reports sent annually).