Tagged with Brazil

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Has an essential or priority drug list been published in your country? (If so provide the link)   Yes. In Brazil, the National List of Essential Drugs (“RENAME”) provides the selection and standardisation of…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What is the definition of an orphan drug in your country? There is no specific definition for orphan drug in Brazilian current rules. However, we understand that it corresponds with the definition of rare…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What is the definition of a vaccine in your country? As per ANVISA Resolution RDC 55/2010, vaccines are immunobiological drugs which contain one or more substances (antigens) that, when injected into an individual, stimulate…

LatAm An overview of some of the biggest stories from Latin American pharma and healthcare, including Brazil’s rollout of dengue vaccines following a sharp increase in cases; the Brazilian  regulatory agency ANVISA’s strategy to become a WHO-listed authority andAspid Pharma’s agreement with Institute for Research on Obesity of the Tecnológico de…

LatAm A roundup of some of the latest stories from Latin American pharma and healthcare, including Sanfer’s acquisition of Columbia-based injectables manufacturer Vitalis; medicine shortages in Colombia, and Chile’s move towards universal primary health coverage with support from the World Bank.   ACON Investments Signs Definitive Agreement to Sell Vitalis to…

Brazil Brazil’s ANVISA is commonly recognised as LatAm’s leading national medicines regulator and is defined by the Pan American Health Organization (PAHO) as a National Regulatory Authority of Regional Reference (NRAr) for medicines and vaccines. As part of our Transformative 2023: Regional Pharma Trends report, PharmaBoardroom’s Patrick Burton explores some of the key recent…

Brazil The latest pharma news from Brazil, including the partnership between Biophytis and Innovation Solutions Pharma; Merck’s 100 years in Brazil; Eurofarma’s USD 100 million biotech investment, and GSK’s green light from ANVISA.   Biophytis and Innovation Solutions Pharma Sign a Partnership Agreement to Accelerate Market Access for Sarconeos in Brazil…

Brazil Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece is focused on HTA Dossiers and Data requirements in the Brazilian pharma market today. Buy The Pharma Legal Handbook: Market Access & HTA – Brazil here for £359.   HTA DOSSIERS Have local authorities published…

LatAm A roundup of some of the latest news from Latin American pharma, including Acino’s acquisition of M8 Pharmaceuticals; AstraZeneca’s growth in Mexico; Neuraxpharm’s expansion into Brazil and Mexico, and Columbia’s decision to issue a compulsory license for GSK/ViiV’s HIV treatment.   Colombia set to issue a compulsory license for an…

Brazil The DIA Global Annual Meeting 2023 hosted DIA’s first regulatory Town Hall fully dedicated to one regulator from Latin America, as leadership from Brazil’s Health Regulatory Agency, ANVISA, shared updates on the country’s regulatory priorities, the agency’s strategic priorities, and local trends, as well as ongoing regulatory convergence and collaboration initiatives. This…

Brazil The latest pharma news from Brazil, including Daiichi Sankyo’s new plant; Bristol Myers Squibb’s re-entry into Brazil’s cardiology market; the Anvisa approval of HIV prevention drug, cabotegravir; Merck’s gamble on the Brazilian obesity market and Novo Nordisk’s patent extension denial.   Japan’s Daiichi Sankyo invests $80 million to expand Brazilian…

Brazil Henrique Tada of ALANAC, the association that brings together Brazil’s domestic pharma companies, comments on the evolution of the Brazilian generics, biosimilars, and value-added medicines markets, local laboratories’ internationalisation efforts, and the policy reforms he hopes that the country’s new administration will roll out.   The pandemic has given us…