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  • Brazil Expedites Device Imports

    Brazil's national regulatory agency, Anvisa, has expedited the process for importing high-risk medical devices (Class III and IV) by agreeing to review devices as soon as its foreign manufacturing site is granted a Certificate of Good Manufacturing Practices (CBPF) by a foreign regulator.  Under the revised procedure (RDC 15/2014), new high tech devices should enter the Brazilian market sooner, since the analysis of the device by the agency can proceed while the ...
  • Brazil to Require Notice One Year Prior to Drug Withdrawal

    Drug manufacturers must now provide a year's notice to Brazil's national regulator, Anvisa, prior to withdrawing a drug from the market if that withdrawal might lead to a shortage of the drug.  The objective of the new mandate, approved on 25 March 2014, is to reduce the potential impact of any drug shortage on the patient population for which the drug is indicated. The 12-month notice mandate also covers situations where the intent is merely to reduce the level...
  • Brazil Pushes Ahead With New Environmental Protection Plan Focused on Drug Disposal

    Brazil's Ministry of Environment (MMA) has issued a final deadline for the pharmaceutical industry to submit its own proposal on how to implement an agreement intended to ensure the environmentally sound disposal of medicines and packaging after use by consumers. The 2010 sectoral agreement requires industry to implement the mandated drug disposal measures within five years in all cities with more than 100,000 inhabitants. This is the third deadline set by the govern...
  • Brazilian Legislators Looking for Enhanced Role in Multi-Country Clinical Trials

    At a hearing on enhancing pharmaceutical research in Brazil, the chair of the Senate Social Affairs Committee, Senator Waldemir Moka, called for the creation of a working group of government agencies and academic researchers who would prepare proposals on ways to bring multi-country clinical trials to Brazil.  Another Senator, Ana Amelia, noted the possible need to revise the existing legal framework governing the conduct of clinical trials in the country, if nec...
  • Brazil Launches New Adverse Event Reporting System

    Brazilian officials are launching an online system for health professionals to report serious or fatal accidents involving defective products or services, including healthcare products.  Health professionals will log adverse events involving drugs, devices, toys, cosmetics and food into a new Consumer Accidents Information System (SIAC) database, initially on a voluntary basis. Reporting will eventually be mandatory. Top of Form The Municipal Hospital of Cuiab&aacu...
  • Similar Drugs in Brazil to Have Same Status as Generics

    Brazilian Health Minister Alexandre Padilha and Dirceu Barbano, director of Brazilian regulatory authority Anvisa, have announced a public consultation on new rules that will grant "similar medicines" the same status as generics. The move will allow pharmacists to provide consumers with a similar drug as a substitute to the branded product. This option, called interchangeability, is currently allowed only for generics. The difference between similars and generics is...
  • Anvisa Approves Track and Trace System

    The board of Brazil's National Health Surveillance Agency, Anvisa, has approved a system that will be used to track drugs from manufacture to the time of sale. Within three years, drug packaging will have a two-dimensional code, and the industry will need to have in place an electronic system to monitor each step of the package, from the factory to the pharmacy. In the case of prescription drugs, the monitoring will go further, with the ability to know who purchased a...
  • Anvisa Unveils New Adverse Event Database

    Brazil's national regulatory agency, Anvisa, has unveiled a new database that will gather information on adverse events relating to blood products, tissues, cells and organs.  The database, which was developed by Italy's National Transplant Center, already includes more than 900 adverse event reports related to cell therapies, organ donations, and assisted reproduction, among others.  The database was first unveiled at the World Health Organization's (WHO)...
  • Brazil's Anvisa to Assess Alternatives to Animal Testing

    The Board of Brazil's National Agency for Sanitary Surveillance (Anvisa) has instructed the agency to review all regulations that require the submission of data from animal experiments to support marketing applications in order to determine situations where it would be possible to use alternative validated testing methods.  The agency is encouraging the development of alternative methods to animal testing through the Brazilian Centre for the Validation of Alterna...
  • Anvisa Sees Sectoral Agreements as New Form of Regulation

    Brazil's National Agency for Sanitary Surveillance (Anvisa) says it sees a new Sectoral Agreement on the disposal of drugs as an innovation in regulation and believes its success will be an important indicator of the viability of the use of such agreements as a regulatory tool. The Agreement, part of Brazil's National Solid Waste Program (PNRS), was realized through the coordination efforts of Anvisa, which vetted its impact and economic viability with the pharmaceuti...
  • New Medicines Trademark Policy Coming in Brazil

    Brazil's National Agency for Sanitary Surveillance (Anvisa) is hosting a public hearing on 24 September 2013 to discuss the criteria that have been proposed for the creation of trade names for medicines in Brazil. The agency's proposal has been the subject of public consultation since it was first proposed in 2010 (CP No. 72/2010) and is intended to minimize or eliminate the possibility of misinterpretation, error or confusion as to the source, origin, nature, composi...
  • Brazil's Anvisa Renews Focus on Nanotechnology

    Brazil's National Agency for Sanitary Surveillance (Anvisa) renewed its cooperation agreement on 9 September 2013 with the country's National Council for Scientific and Technological Development (CNPq).  The renewal particularly foresees cooperative research on the use of nanotechnology in products of interest to health and whether there is a need for regulation targeting such products.  The objective is to fill the existing gaps in scientific technolog...