Clinical Trials In Latin America

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Clinical Research Latin America: pharmaceutical market and regulatory framework

Clinical Research Latin America: pharmaceutical market and regulatory framework

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  • SPEECH NOTES: Hello and welcome. This presentation will briefly discuss the current pharmaceutical market and regulatory framework for clinical trials in Latin America. You will become familiar with the most current legal framework and challenges related to the conduct of clinical trials in the region, with emphasis in the top three markets: Brazil, Argentina and Mexico. References for local regulatory authorities will be provided. Strategies that will help international companies plan implementation of trials as part of global drug development strategy is discussed at the end.

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  • 1. Clinical Trials in Latin America Pharmaceutical Market & Regulatory Framework
      • Juliane Lewis
      • International Regulatory Affairs (410-675.81)
      • Johns Hopkins University
      • December 9, 2008
  • 2. Latin America introduction
    • 21 countries
    • Area: 21, 069, 501 Km 2
    • Population: 569 million people
    • Heterogeneous population
    • Two major official languages: Spanish and Portuguese
    • Average life expectancy: 70 years
    • Infant mortality rate: 13.4 to 109.8/1000 for countries with relatively high income level
    • Population concentration in major urban areas: Mexico City (Mexico), São Paulo/Rio de Janeiro (Brazil), Buenos Aires (Argentina)
    • Estimated population growth: 12.5% by 2015
    • Economic growth rate: 5.3% (2006) = per capita increase: 3.8%
    • GDP: 3.3 Trillion (exchange rate)
    • Sources:
    • Wikipedia.com and World Health Organization (PAHO) web site (1999-2000)
  • 3. Pharmaceutical market
    • 7 major players:
      • Argentina, Brazil, Chile, Colombia, Mexico, Peru and Venezuela
    • 3 top markets:
      • Argentina, Brazil and Mexico
    • Pharmaceutical market
      • USD 50 billion in 2008
      • USD 80 billion projected by 2013
    • Growth differs between countries
      • Challenges:
        • Depends on economic stability
        • Government cost containmet policies
        • IP protection is a concern
      • Opportunities:
        • Generic drugs industry encouraged
        • Health care reforms: more people access to medication
  • 4. Current Clinical Trials
  • 5. Good Clinical Practices harmonization
    • Latin America countries do not participate in ICH decision making process
    • Good Clinical Practices have been adopted by Argentina Mexico and Brazil
    • authorities and they follow the spirit of ICH E6 guideline
    • Pan American Network on Drug Regulatory Harmonization (PANDRH) is the
    • region harmonization effort and office of the World Health Organization (WHO)
    • PANDRH it is part of ICH Global Cooperation Group
    • Growing number of regional conferences and industry collaboration efforts
    • Creation of centralized regulatory authorities in the past decade
    • Guidelines for industry have been published and are available in the web sites
  • 6. Clinical Trials in Brazil
    • Regulatory agency: National Heath Surveillance Agency ( ANVISA )
    • National Biosafety Technical Commission ( CTNBio ): genetically modified organisms and derivatives
    • Resolution 196 of 1996 : Good Clinical Practices ( English version )
    • Resolution 304 of 2000 : supplements 196/1996: native indian population
    • June 5 th 2008: Resolution 39/2008 updated GCP regulation: added sponsor, investigator, CRO responsibilities
    • “ Comunicado Especial” (CE) or Special Communication: official approval notice issued by ANVISA
    • Management Office of Research, Clinical Research, Biologics and New Medical Products (GPBEN)
    • CE required for Phase I, II, III, Phase IV (vaccines only).
    • “ Comunicado Especial Específico (CEE) or Specif Special Communication: all imported products
    • Resolution 136 of 2003 : requirements for registration of new drug products for clinical research
    • CE is necessary for import license (IL). IL process up to 15 days
    • Notification required for Phase IV, medical devices class I, II and non intervention studies
    • All documents must be translated to Portuguese:
      • protocol list published by CONEP and application package list published by ANVISA
    • Foreign sponsors must submit country of origin ethics committee approval document
    • Protocol has two steps approval:
      • Clinical research center ethics committee (CEP): 30 to 60 days
      • National Commission on Research Ethics ( CONEP ): 60 days
    • SISCOMEX (computerized trade documentation system): import/export of clinical research products
    • Must monitor and report serious adverse events in NOTIVISA database
    • Application fee varies. Determined by annual income. Larger companies pay $10,000 Brazilian Reais at the
    • time of application submission
    • Informal assistance is available
    • Web site is a good source of up to date information. VISALEGIS database: current legislation and regulations
    • Note : all links accessed on December 8, 2008 (most in Portuguese)
  • 7. Clinical Trials in Argentina
    • Regulatory agency: National Administration of Food, Drugs and Medical Technology ( ANMAT )
    • Structured web site for GCP norms (Spanish)
    • Disposition 5330/1997 : ethical considerations and requirements for clinical research
    • Resolution 1490/2007 : nation comprehensive good clinical research practices
    • Disposition 969/97 : regulation for clinical research using medical devices
    • Disposition 6550/2008 : published November 5, 2008: additional documentation required and
    • additional texts for terms of responsibility
    • Protocols and related documents translated to Spanish to research center ethics committee: 30
    • days to review
    • Application form: ECLIN 1.0.1 formal process and ECLIBE 1.0.2 for bio equivalency
    • AMAT has 90 working days to make a final decision
    • Protocol amendments require approval (up to 2 weeks)
    • Foreign sponsors must be registered with ANMAT
    • Fee of $5,000 Argentine Pesos at the time of application submission
    • ANMAT Responde : general public consultation information and
    • Informal technical consulation available
    • Current discussion and considerations for paediatric research published by PAHO in AMAT web site
    • Note : all links accessed on December 8, 2008 (Spanish)
  • 8. Clinical Trials in Mexico
    • General Health Law: Title V, Chapter 1, Articles 96-103) details the rules for clinical research ( Health Research 2007 )
    • Clinical research is approved by the Federal Commission for Protection Against Health Risks ( COFEPRIS )
    • Regulation of the General Health Law in the Matter of Health Research (1984)
    • Human Biological Materials: General Health Law, Title XIV, Articles 313-342 (2005)
    • Genetic Research: Biosafety Law on Genetically Modified Organisms (2008) by the
    • National Institute of Genomic Medicine
    • Clinical research must follow scientific and ethical principles (ICH E6 guideline principle)
    • Institutions must have ethics, biosafety and research commission
    • Protocol and related documents must be translated to Spanish
    • Needs sanitary permit priot to import
    • Medical reviewer to research center committee approval: 45 working days
    • Fee of $3585 Mexican Pesos at the time of application submission
    • COFEPRIS information center is CENIF ( National Information Center )
      • free membership: consulation and guidance
      • Note : all links accessed on December 8, 2008 (Spanish) . Consulted source: International Compilation of Human Research Protections (US HHS)
  • 9. Common issues and strategies
    • Strategies for Implementing Trials in Latin America
      • Early planning is essential: site selection and capacity, subject recruitment potential, regulatory
      • procedures and approval times
      • Select the right partner: Clinical Research Organizations with established offices in the region
        • Other options:
        • Regulatory affairs professionals native to the country/region of interest: fluent in native
        • language, understands the culture, laws and regulation
        • Consult independent regulatory experts (IDRAC database)
        • Consult U.S. Human Health Services Compilation of human subjects protection
  • 10. Biopharmaceutical regulatory authorities
  • 11. Juliane Lewis [email_address] Gracias Thank you Obrigada