What is ANVISA?

ANVISA, the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária), is an autarchy under Brazil's Ministry of Health. It plays a central role in the country's health system by regulating products and services that affect public health, including medicines, vaccines, medical devices, and cosmetics. ANVISA is an essential part of Brazil’s National Health Regulatory System (SNVS) and is tasked with ensuring the safety and quality of health-related products and services, as well as controlling their use in various sectors, including international trade.

What is the Role of ANVISA in Brazil’s Pharmaceutical Landscape?

ANVISA is responsible for regulating the production, marketing, and use of medicines, including prescription drugs, over-the-counter medications, and vaccines. It ensures that these products meet health and safety standards before they reach the market. By setting regulatory standards and approving drug products, ANVISA plays a pivotal role in protecting public health while fostering an environment conducive to the pharmaceutical industry’s growth.

ANVISA is a regulatory agency that is active in several healthcare initiatives and works alongside other regulatory agencies. For example, it is also a part of international programs like Project Orbis, which helps accelerate the review and approval of oncology drugs. This partnership with the US FDA allows Brazil to more quickly access innovative treatments, making the country more attractive for pharmaceutical investments. It also helps people in Brazil get access to new therapies faster.

What are the functions of ANVISA in Brazil’s Regulatory Framework?

ANVISA's functions encompass a broad range of activities related to public health and safety:

• Regulation of Pharmaceuticals: ANVISA evaluates and approves medicines and vaccines, ensuring that they meet safety, efficacy, and quality standards before they are allowed to be distributed in Brazil. It also monitors these products post-market to ensure ongoing safety.
• Control of Health Products and Services: Beyond drugs, ANVISA oversees the regulation of other health-related products, including medical devices, cosmetics, and food, ensuring they comply with established health standards.
• Monitoring and Surveillance: ANVISA monitors pharmaceutical production, distribution, and use across Brazil. This includes controlling the safety of products at ports, airports, and borders, which is vital for preventing unsafe goods from entering the market.
• Promoting Health Security: The agency is also responsible for the regulatory oversight of the national health environment, which includes promoting public health initiatives, establishing safety standards, and overseeing compliance with sanitary regulations.
• Global Collaboration: ANVISA is internationally recognized as a reference in the Latin American region. It is working towards achieving a higher level of WHO certification, which would enhance its influence and provide greater access to the global pharmaceutical market.

DDReg’s Capabilities

DDReg offers comprehensive support in navigating the regulatory requirements for pharmaceutical and medical device submissions in Brazil. With a deep understanding of ANVISA's regulatory processes, DDReg helps clients manage their submissions efficiently, ensuring compliance with the latest health standards. Our expertise in both local and international regulatory frameworks enables us to help clients reduce time-to-market while ensuring the safety and efficacy of their products in the Brazilian market.