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  • Regulators Consider New International Coalition of Drug Agencies

    • 20 May 2013
    International regulatory authorities are involved in discussions regarding the possible creation of a new International Coalition for Drug Regulatory Agencies (ICDRA), the Brazilian regulatory agency Anvisa announced on 17 May 2013. The Director of Anvisa, Dirceu Barbano, participated last week in discussions in Rome on the creation (ICMRA). The directors and heads of international affairs at nine agencies debated the scope, objectives and organization of the possible co...
  • Brazilian House Holds Hearing on Anvisa Regulatory Authority

    The Committee on Social Security and Family of Brazil's House of Representatives held a hearing on 9 May 2013 on the scope of regulatory authority of Brazil's National Health Surveillance Agency (Anvisa) with one question in mind: Does Anvisa have too much regulatory authority? The deputy director of Anvisa, Neilton Araújo, argued that several bills introduced in the Brazilian Congress to cut back the agency's regulatory authority would in fact be a setback for ...
  • Anvisa Opens Consultation on Good Regulatory Practices

    Brazil's National Health Surveillance Agency (Anvisa) has opened a Public Consultation on proposed Good Regulatory Practices (GRPs), which establishes the standards and procedures that are to be followed by the agency in the development of regulatory measures. The proposals include a mechanism that would enable Anvisa to assess the best regulatory measure to achieve an intended regulatory goal, which would complement the Regulatory Impact Analysis process. That proces...
  • Brazil Establishes Contingency Process for Dealing With EU API Export Rules

    Under a new plan announced by Brazil's regulatory agency, Anvisa, even if Brazil fails to obtain EU recognition for its active pharmaceutical ingredient (API) good manufacturing practice (GMP) standards by the mandatory date of 2 July 2013, regulators will still provide Brazilian companies with a document indicating GMP compliance so facilitate exports of their APIs. The Falsified Medicines Directive (Directive 2011/62/EU) was adopted in May 2011 to safeguard public he...
  • Brazil Revises Patent Prior Consent Rules

    The board of Brazil's National Health Surveillance Agency (Anvisa) has approved updated rules for the agency's prior consent assessment of patent applications for medicines. The new rules establish a process for prioritizing patent reviews to ensure that the focus is on pharmaceutical products of interest to the public health policies of the country's Unified Health System (SUS). The list of products of interest to the SUS will be published by the Ministry of Health, ...
  • Brazil's Anvisa Looks to Streamline Registration Procedures for Drugs, Devices

    Brazil's National Health Surveillance Agency (Anvisa) has signed a technical cooperation agreement with two other Brazilian agencies designed to sustain the country's economic growth and health by streamlining registration procedures for medical products. The agreement, announced on 10 April 2013, brings together Anvisa with the Ministry of Development, Industry and Foreign Trade (MDIC) and the Ministry of Health (MOH). Under the terms of the inter-ministerial agreement...
  • Brazil Releases Guidance on Drug Manufacturing Decontamination Validation

    Brazil's National Health Surveillance Agency, Anvisa, has released a pharmaceutical production cleaning validation guide which, according to the agency, is based on international guidelines. The document is directed at pharmaceutical manufacturers in Brazil and is intended to be a simple, practical and structured approach for executing the cleaning validation necessary to demonstrate that a company's manufacturing procedures are effective in removing contaminants or low...
  • Brazil Proposes Electronic Tracking System for Drugs

    Brazil's National Health Surveillance Agency (Anvisa) has proposed the formation of an electronic tracking system for drugs that would follow a drug from the point of manufacture to its dispensation to a patient. The proposal was outlined in a consultation announced by Anvisa on 4 April 2013. The proposed tracking system is to be based on the two-dimensional barcode, the Datamatrix, which will be included on sales packaging as well as secondary packaging such as pill ...
  • Brazil to Expedite Review and Approval Process, Recognize Foreign Audits and Inspections

    Brazil's National Health Surveillance Agency (Anvisa) has announced the adoption of a set of measures intended to modernize and expedite the marketing approval review process for new products subject to its regulatory authority. The measures are part of the second phase of the Management Agreement agreed with the Ministry of Health.  According to the CEO of Anvisa, Dirceu Barbano, "Our goal is to improve the operational capacity of the agency; modernize the regul...
  • Brazil Introduces New Online System for Minor Changes to Package Inserts

    Brazil's National Health Surveillance Agency, Anvisa has announced the creation of a new system for filing petitions for minor changes to package inserts through a new online portal on the agency's website.  The new system permits companies to notify the agency immediately of any changes to the leaflet and eliminates the waiting time for the agency to review the changes. Companies can implement the changes almost immediately and they will be available to the publ...
  • Feature ArticlesFeature Articles

    Drug Registration in Brazil: Challenge or Opportunity?

    With its 191 million inhabitants, Brazil is currently the world's eighth largest prescription drug market and has been the target of large investments and significant expectations from big pharmaceutical companies. Registering drugs in Brazil has been a promising strategy for companies from developed countries whose pharmaceutical markets, often governed by repayments, already are saturated and in crisis. These days, the Brazilian National Health Surveillance Agency, AN...
  • Anvisa Signs Cooperative Agreement with Brazil's Anti-Trust Agency

    Brazil's National Health Surveillance Agency (Anvisa) has signed a Technical Cooperation Agreement (TCA) with the Administrative Council for Economic Defense (Cade) in order to investigate potentially anti-competitive conduct by the pharmaceutical industry in the future. The goal of the agreement is to strengthen the relationship with the Council through exchanges of information and the holding of joint meetings, workshops, technical visits, exchanges, studies, researc...