RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    FDA Warns Brazilian OTC Drug Manufacturer

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Brazil’s Mappel Industria de Embalagens last month for four violations, though the over-the-counter (OTC) drug manufacturer told FDA that it did not realize the products were regulated by FDA. FDA’s inspection of the Sao Paulo-based manufacturing facility from 11 April to 15 April found the company: failed to approve or reject all procedures or specifications impacting the identity,...
  • Regulatory NewsRegulatory News

    ANVISA Extends Deadline for Technical Requirement Responses in Brazil

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Brazilian medical device market regulator ANVISA has officially extended deadlines for market applicants to respond to technical inquiries regarding their registration submissions. ANVISA’s technical requirement response deadline, previously 90 days, has been extended to 120 days from confirmation of requirement receipt by applicants. The...
  • Regulatory NewsRegulatory News

    Brazil's ANVISA Granted More Leverage to Prioritize Medical Device-Related Health Risks

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. A new Brazilian law allows ANVISA, the country’s medical device market regulator, greater latitude to manage public health risks and surveillance measures in a way that may also boost efficiencies for Brazilian market registrants. Chapter X of the new  Law 13,097/2015  (link in Portuguese) includes the following changes to the existing AN...
  • Regulatory NewsRegulatory News

    ANVISA to Allow Medical Device Firms to Evaluate Their Inspections

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Brazilian medical device regulator ANVISA has begun accepting  feedback  from medical device companies subject to quality management inspections in order to improve and standardize inspection processes. Firms inspected for Brazilian Good Manufacturing Practice (BGMP) compliance now have the option of submitting a form to ANVISA prov...
  • Regulatory NewsRegulatory News

    Anvisa Launches Drug and Device Monitoring Program

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazilian regulator Anvisa has launched two programs for monitoring the quality of medicines and health products in Brazil.  The National Program for Quality Control of Medicines (Proveme) will initially analyze monthly samples of drugs from Aqui Tem Farmácia Popula...
  • Regulatory NewsRegulatory News

    Brazilian Device Industry Prepares for eSubmissions

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazil's medical device industry should prepare for electronic submissions, Anvisa, Brazil's national regulatory agency, said at a 20 August 2014 meeting . The meeting provided an opportunity for the agency to discuss its implementation strategy for the International ...
  • Regulatory NewsRegulatory News

    Anvisa to Develop Standards and Guidelines for Nanotechnology Products

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazil’s national regulatory agency, Anvisa, has established a multidisciplinary Nanotechnology Committee within the agency with the mandate to develop standards and specific guidelines for the evaluation and regulation of products that use nanotechnology.  In additio...
  • Regulatory NewsRegulatory News

    Brazilian Regulators Propose Amendments to Country's Clinical Trial Rules

    This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazil’s national regulatory agency, Anvisa, announced on 4 August 2014 that it has opened consultations on two separate proposed regulations that would amend existing procedures governing clinical trials with both drugs and medical devices. The first, CP 64, targets medica...
  • Regulatory NewsRegulatory News

    Brazil Update: New Pharmacopeial Methods, Microbiology Testing Standards

    This content is provided by RegLink Associates . Read all of their Breaking News alerts on their website. Anvisa Proposes Alternative Pharmacopeial Methods Brazil’s national regulatory agency, Anvisa, is inviting comments on proposed alternative Pharmacopeial microbiological methods that can be used to replace those currently listed in the Brazilian Pharmacopoeia, with faster and better results.  The proposal complements the framework of documents t...
  • Feature ArticlesFeature Articles

    Considering a Business Presence in Latin America? What You Should Know about Regulatory in the Region

    When considering expanding or relocating to Latin America, companies typically focus on business decisions. Should an office be established in each country or should business be done through local distributors? Often, companies neglect to design a specific regulatory strategy, even though regulatory issues are an important element in an effective business plan. Challenges to Latin American Marketing There are many reasons a company should consider regulatory the ...
  • Regulatory NewsRegulatory News

    Brazil's Anvisa Pushes Expedited Approvals for Generics, Biologics

    Brazilian regulator Anvisa has launched a simplified procedure (RDC No. 31) for the registration, post-registration and renewal of registration of generic, similar, herbal, biologic, “dynamized” and “specific” drugs.  So-called "dynamized" drugs in Brazil are preparations from substances that are subjected to successive dilutions, that are administered as homeopathic, anthroposophic or homotoxicological therapy.  Specific drugs are products that do not fit int...
  • Brazilian Pharma Sector Submits Drug Waste Proposals

    After several extensions of the deadline by the Brazilian government, the Brazilian pharmaceutical sector has finally submitted three suggestions to the Ministry of Environment for a pharmaceutical sectoral agreement on the disposal of medicines by consumers  . After review by the Ministry, a final proposal will be submitted for consideration to the Steering Committee for the Implementation of Reverse Logistics Systems (CORI), which is coordinated by the Ministry ...