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Anvisa’s Innovation Policy: What It Is and How It Can Impact the Healthcare Sector in Brazil.

Innovation in health is an increasingly relevant topic for the development of the sector and the improvement of the population’s quality of life. Therefore, it is important to be aware of initiatives aimed at promoting and supporting healthcare innovation in Brazil, such as ANVISA’s Innovation Policy, which was recently published.

ANVISA’s Innovation Policy is a set of regulatory actions that aim to promote health innovation in the country by encouraging the development of innovative, safe, and effective products and services. The policy is based on four strategic pillars: regulatory environment conducive to innovation, articulation and cooperation with relevant stakeholders, knowledge and information management, and an organizational culture focused on innovation.

The first pillar refers the creaction of a regulatory environment that favors innovation in health, through the adoption of measures such as simplifying processes, making requirements more flexible, reducing deadlines, prioritizing demands, incorporating new technologies and methodologies, assessing regulatory impact, and periodic review of current standards.

The second pillar refers to articulation and cooperation with relevant actors to health innovation, such as government agencies, representative entities of the regulated sector, educational and research institutions, international organizations, foreign regulatory agencies, and civil society. The objective is to promote dialogue, exchange, technical cooperation, and alignment of interests among different actors.

The third pillar refers to the management of knowledge and information about health innovation through the production, dissemination, use, and updating data, information, and scientific evidence that support regulatory decisions and guide agentes involved in healthcare innovation. The objective is to increase access to information, strengthen the technical and scientific capacity of ANVISA and other actors, and also foment an evidence-based culture.

The fourth pillar refers to the organizational culture focused on innovation at ANVISA , through the development of competencies, skills, and attitudes that stimulate creative thinking, experimentation, continuous learning, adaptation to change, risk tolerance, tolerance for errors, collaboration, and sharing of ideas among the agency’s employees. The objective is to create an environment favorable to innovation within ANVISA.

he policy also defines ANVISA’s principles, guidelines, objectives, and responsibilities in implementing the policy, which involves several technical areas of the agency, as well as representatives from the regulated sector, academia, government, and civil society. The initiative is part of ANVISA’s 2020-2023 Action Plan, which has as one of its strategic goals to foment innovation in health in the country.

ANVISA’s Innovation Policy is an important milestone for strengthening the health innovation ecosystem in Brazil, which can bring benefits to patients, healthcare professionals, public and private managers, researchers, entrepreneurs, and investors. Passarini Group closely monitors updates about the policy and supports initiatives that aim to boost health innovation in Brazil.

To find out more about ANVISA’s Innovation Policy, access the link below:

Publication of #RDC No. 810 modifies RDC No. 751

For further information, please contact Passarini Group! We will be pleased to assist you via email: [email protected].

Passarini Group

Published on: 10/11/2023 – Source: ANVISA

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