ANVISA’s Innovation Policy Established by Ordinance 1,100/2023

by | Oct 9, 2023 | Blog, Life Sciences, Pharma

On October 2, 2023, Ordinance 1,100/2023 was published, establishing ANVISA’s Innovation Policy. This measure aims to enhance the agency’s ability to address complex and unforeseen challenges while promoting the development and adoption of innovative products and services based on new technologies in Brazil. ANVISA now includes innovation among its institutional objectives.

Among the principles of innovation management, a commitment to the well-being of the population stands out. In other words, the promotion of innovation should be directed toward addressing public health issues, addressing emergency situations, and improving the health of the Brazilian people while respecting transparency and legal, moral, and ethical aspects.

Additionally, ANVISA intends to collaborate with various stakeholders, including government agencies, universities, private companies, and civil society, to identify problems and innovative solutions. Optimizing existing competencies and capacities is another important focus, encouraging the participation of professionals within the National Health Surveillance System (SNVS) and valuing their experiences.

The Innovation Policy is based on three main axes, with several guidelines to create strategies and initiatives for its implementation. The axes include: promoting a culture and capacity for innovation, adopting technology and digital transformation, and enhancing healthcare regulations and access.

The implementation of the Innovation Policy will align with the policies of the Unified Health System (SUS), the principles of Digital Government, the National Innovation Policy, and ANVISA’s Corporate Risk Management and Organizational Governance policies.

ANVISA and its unit directors are expected to collaborate in implementing the Innovation Policy. The Strategic Management, Risk, and Institutional Innovation Committee (CGE) will be responsible for monitoring the implementation and assessing the results of this policy.

ANVISA will also be able to establish partnerships with public or private institutions, both national and international, and hire individuals to conduct scientific research, technological development, and innovation activities in products, services, or work processes.

We believe that ANVISA’s Innovation Policy aligns with the guidelines of the National Strategy for the Development of the Economic-Industrial Health Complex (CEIS), established in GM/MS Ordinance 1,354, dated September 27, 2023, which we will further address in our next post regarding this issue.

If you have any questions or would like to get more information, do not hesitate to get in touch with our team.

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