Fiocruz asks for inclusion of BioManguinhos as a national API producer

Forecast is for completion of the process in 30 days

Published in 26/11/2021 - 16:53 By Cristina Indio do Brasil - Repórter da Agência Brasil - Rio de Janeiro

The Institute of Technology in Immunobiologicals of the Oswaldo Cruz Foundation (Bio-Manguinhos/Fiocruz), forwarded to the National Health Surveillance Agency (Anvisa) the request for a post-registration change in the covid-19 (recombinant) vaccine, requesting the inclusion of the institution as unit producing the Active Pharmaceutical Ingredient (API) of the immunizing agent. The request was delivered yesterday (25) and Fiocruz forecasts that the process will be completed in 30 days by the regulatory agency.

According to Fiocruz, this is a technology transfer process in record time. According to the Foundation, in general, technology transfers in immunobiologicals usually take about 10 years to be completed. “With the Fiocruz Covid-19 vaccine, Bio-Manguinhos/Fiocruz will complete the incorporation of the technology in just one year, in response to a health emergency”, he added.

The Bio-Manguinhos/Fiocruz Institute took about two months to prepare the necessary documentation for the new submission. During this period, he participated in three meetings via parlatory, with Anvisa, to deal specifically with the request to change the manufacturing location of the API. “The submission of the request takes place within the deadline set by Fiocruz”, he pointed out.

To give a favorable opinion, Anvisa needs to assess the equivalence of the production process, proving that vaccines produced with the Bio-Manguinhos/Fiocruz API have the same efficacy, safety and quality as immunizing agents processed with the imported Ingredient, in addition to analytical methodologies required and the stages of the production process.

The phase is the last regulatory step for Brazil to have 100% national vaccine. In the previous step-by-step, Anvisa had already granted the Technical-Operational Conditions (CTO) of the Ingredient production infrastructure and the Certificate of Good Manufacturing Practices (cBPF) for the production of this input. During the analysis of the regulatory agency, more data may be presented, in addition to those that have already been delivered to Anvisa in the package for the request to change the manufacturing location of the IFA.

100% national

Fiocruz informed that so far, it has produced five batches of national API. Among them, four were released internally and are in analytical comparability studies abroad. In addition, three others are currently being processed at the Institute.

Also according to Fiocruz, the final processing, which comprises the formulation, filling, review, labeling and packaging of batches, with the national IFA and the first deliveries of national vaccines will only occur after approval of the post-registration change by the Anvisa and agreement with the National Immunization Program (PNI). “In order to guarantee the maximum validity of the doses at the time of distribution”, he added.

Text translated using artificial intelligence.

Edition: Maria Claudia

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