CGU audit recognizes Anvisa’s excellence in good regulatory practices; learn how this reflects on healthcare product regulation and how QR Group supports manufacturers.
The Office of the Comptroller General of the Union (CGU) recently evaluated Anvisa, along with other regulatory agencies, regarding the adoption of good regulatory practices. Anvisa stood out for meeting all the criteria established by the audit, receiving maximum performance. QR Group, a specialist in health product regulation, can help your company navigate ANVISA regulations with agility and accuracy.
Impacts of Anvisa’s Good Regulatory Practices on the Health Industry
With the CGU audit highlighting Anvisa as a leader in good practices, it is important to understand how these practices directly impact the health product regulation process in Brazil. The analysis focused on five key criteria:
- Use of the Regulatory Agenda and Associated Good Practices: Anvisa strictly adheres to its regulatory agenda, maintaining a clear and transparent timeline for regulations and updates.
- Regulatory Impact Analysis (RIA): The Agency follows Decree 10,411/2020, carrying out analyses that ensure that new regulations are implemented effectively and with the least possible impact on the market and the population.
- Social Participation in the Regulatory Process: Anvisa promotes participatory processes, ensuring that society and stakeholders can influence rules and regulations.
- Regulatory Outcome Assessment (ARR): Anvisa adopts the Regulatory Outcome Assessment, allowing public policies and regulations to be constantly evaluated for greater effectiveness.
- Review of the Normative Stock: The continuous review of the rules, according to Decree 10,139/2019, allows Anvisa to adapt to the new needs of the market and public health, ensuring always up-to-date regulations.
How QR Group Facilitates ANVISA Compliance
QR Group, with its expertise in health product regulation, can help your company quickly adapt to ANVISA’s requirements, ensuring full compliance. Our team offers agile and effective solutions for ANVISA petitioning, regulatory consulting and adaptation to new standards. By understanding the impacts of regulatory changes and compliance requirements, our company makes the process easier for international and domestic manufacturers.
If you are a manufacturer of health products and looking to ensure compliance with ANVISA regulations, contact QR Group. Our team is ready to offer quick and efficient solutions, ensuring that your company meets the highest regulatory standards.
Source: ANVISA
