The National Health Surveillance Agency (Anvisa) published a technical note to simplify the procedure for data analysis and registration of vaccines against covid-19 in the country. The note reduces requirements for admission of the protocol for new products. The proposal, presented yesterday (29), determines that after the inclusion of the information, the team will analyze documentation within 20 days.
The procedure, called continuous submission, says that the analysis of the data related to the immunizers will happen as the results of the research are generated and presented to Anvisa, “aiming at a later registration submission when the necessary regulatory requirements are fulfilled”.
“As of the adoption of this procedure, it will not be necessary to wait for the availability of all technical data and documents, as well as the fulfillment of regulatory requirements, to perform the registration submission with Anvisa. In other words, as the data is generated, these must be submitted to the Agency, so that the regulatory process is streamlined, “informed Anvisa.
According to the regulatory agency, the strategy aims to speed up the availability of vaccines against the new coronavirus to the Brazilian population, provided quality, safety and efficacy are guaranteed.
According to the technical note, the application for registration of the possible vaccine must be filed with a justification and contain information about the status worldwide regulatory framework, history of the applicant’s previous interactions with Anvisa and a schedule for submitting the technical documentation to be evaluated.
At each new stage, an addition should be made with information about the research. It will be up to Anvisa to analyze the documentation within 20 days, “depending on the amount of data submitted, counted from the date of the protocol.”
The procedure will be repeated with each new submission of information. The number of amendment cycles will depend on the number of packages to be submitted by the interested company, with no limit imposed by Anvisa for this number.
“Products that have their analysis initiated by the continuous submission procedure may have submitted their formal registration request after the completion of the last protocoled amendment and after evaluation by the company as to the sufficiency of quality, efficacy and safety data for the establishment of a relationship positive and robust benefit-risk balance, considering the therapeutic indication sought and previous discussions with Anvisa ”, says the technical note.