• Regulatory NewsRegulatory News

    Caribbean Regulatory System Begins Recommending Generic Drugs

    The Caribbean Public Health Agency/Caribbean Regulatory System (CARPHA/CRS) last month kicked off its work advising Caribbean countries’ governments by assessing and recommending four generic HIV treatments. The recommendations, which follow approval from WHO, included emtricitabine/tenofovir and tenofovir tablets, also known as generic versions of Viread and Truvada (a generic of which also recently won US FDA approval ). The regional initiative is meant to help ...
  • Regulatory NewsRegulatory News

    South American Health Ministers Negotiate Lower Prices for Antivirals, Antiretrovirals

    As the drug pricing debate continues in the US, the ministers of health of 10 Latin American countries recently persuaded pharmaceutical companies to lower the prices of several HIV/AIDS and hepatitis C treatments. In the first of two planned rounds of negotiations, the health ministers of MERCOSUR (which includes Argentina, Bolivia, Brazil, Paraguay, Uruguay, Venezuela and associate countries Chile, Peru, Colombia and Ecuador) earlier this week agreed to purchase the HI...
  • FDA to Spend up to $10 Million Strengthening Regulation in South America

    • 17 July 2014
    US regulators are planning to work more closely with a global health group focused heavily on South America in the hopes of strengthening medical product regulatory systems across the region. In an announcement on 8 July 2013, the US Food and Drug Administration (FDA) said it plans to award the Pan American Health Organization (PAHO) a contract to help "foster regulatory collaboration and strengthen regulatory capacity throughout the Americas." Regulatory capacity broad...
  • Brazilian, Global Regulators Focus on Pharmacovigilance

    Together with the World Health Organization (WHO) and the Pan American Health Organization (PAHO), Brazil's National Health Surveillance Agency (Anvisa) recently hosted two international meetings on pharmacovigilance in Brazil, bringing together countries from Latin America and around the globe. Both meetings provided the opportunity to further integrate post-marketing surveillance activities in the Latin American and Caribbean region. Delegations from 59 countries, incl...
  • HTA Focus of PAHO Sponsored Group

    • 07 May 2012
    José Agenor Alvarez, Director of Brazil's national agency, Anvisa, attended the 3rd meeting of the Pan American Health Organization (PAHO) supported Network for Technology Assessment in Health of the Americas (RedTSA). Since Brazil is developing a national health system, Anvisa sees Health Technology Assessment (HTA) as an essential tool for incorporating new technologies into the health system. The RedTSA meeting was held in Lima Peru on 26-27 April, with repres...