Journal of Bioequivalence & Bioavailability

Regulatory transparency: Key aspects throughout access BA/BE report

6^th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit

August 17-19, 2015 Chicago, USA

Varley Dias Sousa1,2 and Damaris Silveira1

Posters-Accepted Abstracts: J Bioequiv Availab

Abstract:

Introduction: Brazil is the 5th biggest pharmaceutical market in the world, and the Brazilian Heath Surveillance Agency (ANVISA)
is responsible to evaluate the products quality and safety. Hence, in the field of health regulation, the wide access to data of drugs and
related technical documents, especially BA/BE report data, is in expansion at FDA, EMA and ANVISA. A fact to be evaluated is how
disclosure policies are built, emphasizing the regulatory impact analysis and detecting the risks and benefits involved. Bioavailability
and Bioequivalence Studies (BA/BE) is essentially significant as contain vital information regard drug variability and pharmacokinetic
profile over and above is the primary source of information about product efficacy (Generics or multisource products).
Discussion: Actually the Brazilian Electronic Database (Sineb) has more than 2000 BA/BE reports of which 30% had negative results,
but none of these trials are available for public consultation. Around 300 studies were pilots, performed in order to gain knowledge
(Pharmacodynamics/Pharmacokinetic) about the API (Active Product Ingredient). The openness will enable public scrutiny and
secondary analysis probably resulting in improvement of the products quality and public health development as well as the social
accountability. Over and above the reanalysis will reinforce confidence over Agency´s skills, in the other hand inappropriate reanalysis
or methodologically flawed can mislead treatment adherence or public health programs.
Conclusion: Responsible public disclosure of BABE reports lead to improve the common knowledge about API characteristics
avoiding unnecessary studies as well as protecting voluntaries integrity. However, some boundaries should be respected in order
to not frustrate investments on bio-pharmaceutical research and development (R&D) along with not to bias the Agency’s decisionmaking
process. After all, decreasing the number of tests imply lowering the registers costs.