ANVISA has launched Call No. 1, aimed at supporting the development of phytotherapeutic drugs, new synthetic drugs and biological products of interest to healthcare services by medical startups.
Recognizing the critical need for new medications and the importance of nurturing innovation within Brazil’s healthcare ecosystem, Anvisa has designed this program specifically for Brazilian medical startups. By doing so, it reinforces the regulatory body’s role in promoting health-related innovation and development.
The programme is in line with the guidelines of the National Strategy for the Development of the Economic-Industrial Complex of Health and ANVISA’s Innovation Policy, which aims to accelerate the market access of new medicines to meet the urgent medical needs of the population.
Selection of start-ups
Three start-ups, each developing a phytotherapeutic drug, a new synthetic drug and a biological product, will be selected to participate in the pilot project on regulatory evaluation. The primary objective is to help these companies navigate the health regulations from the early stages of product development.
Regulatory support
The initiative aims to provide specific regulatory support to facilitate compliance with health requirements and accelerate the process of pharmaceutical innovation in the country. In addition, it aims to provide insights to improve ANVISA’s guidelines and support strategies for innovation in the pharmaceutical sector.
Requirements for participation
Candidates must demonstrate innovative potential and relevance to the treatment of diseases with a significant impact on public health, as well as meet specific criteria detailed in the call, including the stage of drug development and the institutional capacity of the medical start-up company.
Application process
Participation is by completing an electronic form (https://pesquisa.anvisa.gov.br/index.php/868758?lang=en) detailing the proposed stage of drug development.
Selection criteria and tie-breakers
Priority will be given to drugs for the treatment of diseases with high morbidity and mortality rates in Brazil, with a clear impact on the National Health System (SUS) and in advanced stages of development.
Deadline for applications
Interested parties have until 7 May to submit their proposals.
