High Performance


ANVISA – Radical Regulatory Innovation

A set of actions for an innovative regulatory environment.

The workshop held on October 16th at the headquarters of the National Health Surveillance Agency – ANVISA, brought together the public and private sectors to discuss topics related to radical innovation in the pharmaceutical field in order to join efforts to strengthen the Brazilian innovation ecosystem and contribute to reducing the vulnerability of the Unified Health System (SUS).

The event aimed to:

I. Promote a discussion to develop a regulatory strategy for radical innovation in Brazil.

II. Present and discuss the results and actions carried out by Abiquifi, in partnership with ApexBrasil, to strengthen the ecosystem of radical innovation in the country.

INNOVATION ECOSYSTEM Among the key points, attention should be given to the pillars of the Innovation Ecosystem, which reflect:

• Intelligent, flexible, and adaptable regulations – Regulations should be flexible enough to allow the development of new drugs, even if they do not fit traditional standards.

• Accelerated approval programs – These can enable new drugs to be approved for use before completing all traditionally required clinical tests or have their evaluation accelerated/prioritized for the treatment of severe and/or rare diseases with no therapeutic alternatives.

• Access to financial resources – Radical innovation in the field of pharmaceuticals is a costly and time-consuming process. It’s important to ensure that researchers have access to sufficient financial resources for research and development.

• Tax incentives – The existence of tax incentives can help free up company resources to invest in more innovative projects.

• Collaboration between the public and private sectors – Partnerships between governments and pharmaceutical companies for the development of new drugs. Funding for basic research. These collaborations can help share resources, expertise, and risks inherent in the innovation process.

FDA In addition to these, the event highlighted the FDA’s support for radical innovation through:

• Innovative Therapy Designation • Fast Track Designation • Orphan Drug Designation • Pediatric Rare Diseases Priority Review Voucher Program • Master Protocols Program • Complementary Initiatives

EMA Similarly, it showcased EMA’s support for radical innovation:

• Prime – a program designed to provide early and intensive scientific and regulatory support to sponsors of promising new drugs. • Regulatory Science – EMA invests in regulatory science research to develop new tools and methods to support the evaluation of new drugs. • Adaptive pathways – Allows developers to collect patient data as the drug is developed and use that data to inform the design of future clinical trials. This can help reduce the time and cost of drug development. • Office for Small and Medium-sized Enterprises – Support for startups, small, and medium-sized enterprises developing drugs to promote innovation and the development of new drugs through advice, guidance, and regulatory assistance.

STARTUPS Regarding startups, the Agency noted that it currently does not have an implemented or outlined guidance or counseling program.

However, it expressed its intention to understand the aspirations, needs, and opportunities for ANVISA’s role, or even for the Brazilian innovation ecosystem.

“But we want to understand the aspirations, needs, and opportunities for ANVISA’s role, or even for the Brazilian innovation ecosystem.”

“Regulation in Brazil is often associated with bureaucracy or obstacles. We want to change that perception. We want ANVISA’s role to also serve as a catalyst for innovation processes in the country, for the benefit of the Brazilian population.”

It is worth noting that the meeting is part of a national agenda that aims to create a favorable environment to boost Brazilian startups and encourage the participation of foreign startups in the country. The workshop was organized by ANVISA in partnership with the Brazilian Association of Pharmaceutical Input Industry (Abiquifi), with the support of ApexBrasil and the Ministry of Development, Industry, Trade, and Services (MDIC).

Access the full document here.

Access the full event on YouTube here.

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