In mid-July, ANVISA’s Clinical Research Coordination (COPEC/ANVISA) published Service Orientation (OS) No. 88/2020, which provides for the analysis of the required documents for submitting the Clinical Development Dossier of Medication (DDCM). The OS also guarantees recognition of approval opinions for clinical development dossiers by other regulatory authorities, thus allowing for faster and more predictable clinical research approval in Brazil.
Interfarma, through its Clinical Research Commission, has since the beginning of 2020 worked in partnership with COPEC in elaborating the OS. The initiative aimed to improve the Brazilian regulatory environment, making it more favorable and attractive for new clinical research, without compromising the principles of good clinical practices, as well as the quality and safety of studies.
ANVISA also defined procedures for continuous submissions of technical data for the registration of vaccines against Covid-19, through Normative Instruction No. 77/2020. Thus, companies can now share information about ongoing studies partially and in a continuous way, which speeds up the analysis of reports by ANVISA”s technical staff.
Yet another Interfarma action for improving Brazil’s regulatory environment is related to approving Bill 7,082/2017, which creates the National System of Ethics in Clinical Research with Human Beings. In August, Interfarma and 22 health entities sent Congressman Rodrigo Maia (DEM/RJ), President of Brazil’s Chamber of Deputies, a letter requesting urgent approval for the Bill on Clinical Research.