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Clinical Trials In Latin America

Clinical Research Latin America: pharmaceutical market and regulatory framework

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Clinical Trials In Latin America

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