Country Focus: Brazil
Brazil’s pharmaceutical market is the 11th largest in the world and second in Latin America after Mexico. The value of the pharmaceuticals market increased from $15.4 billion in 2009 to $25.3 billion in 2016. The medical device market was worth $7.1 billion in 2009 and reached $9.7 billion in 2016—it is forecast to hit $14 billion in 2021. According to research firm GlobalData, these growth trends can be primarily attributed to an increasingly elderly population and more accessibility to healthcare professionals in remote areas.
Brazil’s Regulatory Landscape
The role of regulatory authorities is to ensure the quality, safety and efficacy of all medicines in circulation in their country. It not only includes the process of regulating and monitoring the drugs but also the process of manufacturing, distribution and promotion of it. One of the primary challenges for regulatory authorities is to ensure that the pharmaceutical products are developed as per the regulatory requirements of that country/region, in this case, Brazil and Latin America.
The federal regulatory agency responsible for pharmaceutical product registration in Brazil is Anvisa (National Sanitary Vigilance agency), which was established in 1999. Anvisa’s primary goal is to protect and promote public health, by exercising health surveillance over products and services, including processes, ingredients and technologies that pose any health risks. It is a governmental regulatory agency “characterized by its administrative independence, financial autonomy, and the stability of its directors.” Anvisa is ruled by a Collegiate Board of Directors composed of five members. In the federal public administrative structure, the agency is connected to the Ministry of Health. The agency is also responsible for health control in ports, airports and borders, as well as for establishing relations with the Ministry of International Affairs and with foreign organisms and institutions to deal with international affairs regarding health surveillance.
According to the Brazilian legislation, all the pharmaceutical products must be registered with Anvisa before coming to market in Brazil. Product registration in Brazil can be a laborious exercise, and is to be requested by the local Brazilian based office of the foreign company or its distributor in Brazil. The registration is valid for five years and can be renewed continuously for the same period. The registration process must be completed within 90 days after the registration is requested, or denied.
In March 2013, Anvisa released Technical Regulation of Good Manufacturing Practices of Medical Devices and In Vitro Diagnostic Devices. These technical regulations describe, in detail, the quality system requirements, process and production controls, handling and storage, correction and preventive actions and more.
To get pharmaceutical or medical device products approved for sale and distribution in Brazil, Anvisa imposes protocols for the import of new drugs which require processes be followed and certain documents be translated into Portuguese. These include:
- Good Manufacturing Practices of importing country or inspection by Anvisa.
- Translation of labeling and package inserts into Brazilian Portuguese. Official documents, such as certificates provided by the importing country, must also be translated.
- Certain documentation is allowed in Portuguese, English or Spanish language. Welocalize Life Sciences can guide you through this process of what does and does not need to be translated.
Welocalize Life Sciences has two decades of experience translating documents for the Brazilian market, including marketing authorization dossiers (non-clinical, clinical and quality documentation), package inserts as well as labeling and marketing authorization variations.
For more information about regulatory requirements for Brazil and professional Portuguese and Spanish language services, contact us.