Journal of Clinical Trials
Open Access
ISSN: 2167-0870
+44 1478 350008
ISSN: 2167-0870
+44 1478 350008
Varley Dias Sousa1,2 and Damaris Silveira1
Posters-Accepted Abstracts: J Clin Trials
Brazil is 5th biggest pharmaceutical market in the world and the Brazilian Heath Surveillance Agency (ANVISA) is responsible to
evaluate the products quality and safety. The process of expanding access to data on the regulatory framework was highlighted
by publication of Federal Law 12.527/2011. Hence, in the field of health regulation, the wide access to data of drugs and related
technical documents, especially clinical trials data, is in the expansionat 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. Therefore, is
essential the analysis of the legal, technical and ethical aspects involved in the publicity of data, such as: Patent rights, confidentiality
of commercial information, privacy of research subjects, rules of engagement for accessing, clinical trials registers, electronic
application, as well as defining the limits of access and disclosure. 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 but
some boundaries should be respect in order to not frustrate investments on bio-pharmaceutical research and development (R&D)
along with not to bias the Agency’s decision-making process, hereafter, disclosures policies has substantial impact over Regulatory
Environment. Clinical Study Report is essentially significant as it contains vital information regarding new products, methods and
formulations over and above is the primary source of information about the product efficacy.
Varley Dias Sousa is a Pharmacist (2003), Post-Graduated on Health Surveillance (2007), and International Health Systems (2006), and has completed his MSc in
2010. Currently he is performing PhD studies at the University of Brasilia. He is a senior Auditor on Brazilian Health Surveillance (ANVISA) since 2005, he has been
certified in Good Manufacturing Practices (inspecting international facilities in almost 10 different countries) and Good Clinical and Laboratory Practices (Inspecting
more 30 international CROs). He has evaluated more than 150 bioavailability and bioequivalence (BA/BE) studies and more than 150 Medicine Applications. Also,
he is the member of the commission in charge of confidentiality classification on Medicine Dossier.