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  • Brazilian Good Practices Certification Process Simplified

    Brazil's National Agency for Sanitary Surveillance (Anvisa) published a  new resolution  (RDC No. 39/2013) on 16 August 2013 that replaces ten previous resolutions with a single administrative standard governing Good Practices Certification (GPC) and the definition of criteria for automatic renewal of such Certificates for medicines and medical devices, as well as cosmetics.   The new standard simplifies the contents of certificates of Good Manufactur...
  • Brazil's President Signs Anti-bribery Law

    • 16 August 2013
    Brazilian President Dilma Rousseff has signed  the  Brazilian Clean Companies Act  (BCCA), which for the first time subjects Brazilian and foreign entities having a registered office in Brazil to civil and administrative sanctions for bribing either Brazilian or foreign public officials. Though not specifically targeted as the life sciences sector, the new law will have implications for all companies doing business in that Brazil. The BCCA prohibits t...
  • Brazil's Anvisa to Implement Programs Improving Patient Access to Experimental Drugs

    Brazil's National Agency for Sanitary Surveillance (Anvisa) published a new regulation ( Resolution RDC 38/2013 ) on 13 August 2013 that sets forth several pathways for providing patients access to drugs before they are approved. The first is a Compassionate Use program framework, in which Anvisa provides authorization for the provision, under a public welfare program, of a promising access to a new drug without agency registration for the treatment of rare and serious d...
  • Anvisa to Open Consultation on New Traditional Herbal Product Category

    Brazil's National Agency for Sanitary Surveillance (Anvisa) has announced the opening of a public consultation (34/2013) proposing a new category of traditional herbal (non-prescription) products. The proposal would update the rules for the registration of herbal medicines with a new traditional herbal product class, in which product effectiveness and safety could be established through reports of traditional use and literature references. Under the proposal, the herba...
  • Brazil Suspends Certification Process for Foreign Bioequivalence and Bioavailability Test Centers

    Brazil's National Agency for Sanitary Surveillance (Anvisa) has suspended processing of new applications for primary certification of bioavailability or bioequivalence for medical products by research centers located outside the country. Applications filed prior to 31 July 2013, the date the suspension entered into force (RDC 37/13), will still be processed, regulators said. The purpose of the suspension is to facilitate the review of existing rules governing foreig...
  • Brazil Proposes New Traditional Herbal Products Classification

    The Board of Brazil's National Agency for Sanitary Surveillance (Anvisa) approved on 30 July 2013 the launch of a consultation on the creation of a new category of traditional herbal products whose effectiveness and safety could be established through reports of traditional use and literature references.   Once finalized, the proposal would create two separate categories of products, herbal medicines and traditional herbal products.   The tradition...
  • Brazil's Anvisa to Open Consultation on Single-Facility Multiple-Product Production

    Brazil's National Agency for Sanitary Surveillance (Anvisa) will soon open a Public Consultation (No. 26/2013) on a proposal to permit the production of veterinary pharmaceuticals, medical devices, cosmetics and toiletries in the same manufacturing site where human medicines are produced, it has announced. Anvisa's said the proposal would, in its opinion, bring Brazil into alignment with regulatory policies in most other countries surveyed by the agency. Anvisa noted t...
  • Brazil Opens Consultation on API Manufacturing Change Notifications

    Brazil's National Agency for Sanitary Surveillance (Anvisa) opened a public consultation (Consultation No. 22/13) on 12 July 2013 concerning new requirements for reporting manufacturing changes for active pharmaceutical ingredients (APIs). The proposal provides a classification system as to the types of possible changes and the reporting procedures that should be adopted in each case. The manufacturer would have to notify Anvisa of changes according to the impact on t...
  • Anvisa Proposes Mandatory Notice for Manufacturing Suspension

    The Board of Brazil's National Agency for Sanitary Surveillance (Anvisa) has opened a consultation on a proposal that would require companies to provide at least 180 days of advance notice to Anvisa prior to discontinuing, reducing or temporarily suspending the manufacture or importation of essential drugs.  In cases where the action is being taken due to technical reasons that could impact drug quality, safety and/or efficacy, notice would have to be provided to...
  • Manual of Brazilian Nonproprietary Names Launched

    Brazil's National Agency for Sanitary Surveillance (Anvisa) has launched the country's first Manual of Brazilian Nonproprietary Names (MDCB), drawing on legislation related to the Brazilian Common Denomination (DCB) system and its supplemental tables. The Manual, which launched on 26 June 2013, contains over 11,000 designated names and permits the standardization of names for the identification of generic drugs and for drug procurement. The launch is part of the II ...
  • Brazilian Regulators Propose Switching From Paper to Electronic Permit Submissions

    Brazil's National Agency for Sanitary Surveillance (Anvisa) has opened a consultation (20/2013) regarding its proposal to switch from paper-only to e-format-only submissions for Operating Permits (AFE) and Special Authorizations (EA), documents that are necessary for any company that has Anvisa-regulated products such as medicines. The proposal also would: establish automatic renewal of AFEs and EAs harmonize the technical requirements that must be met by companies...
  • Head of Brazil’s Drug Price Control Agency Set to Head Anvisa

    • 13 June 2013
    The Social Affairs Committee (CAS) of Brazil's Senate has approved the appointment of Ivo Bucarescky as the new head of Brazil's National Health Surveillance Agency (Anvisa), with the full Senate set to vote on the appointment as early as June 12.   Bucaresky must now leave his position as the executive secretary of the Medicines Market Regulatory Agency (CMED), whose main mission is to set drug prices in Brazil. He is a graduate of the Institute of Economics of t...