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Latin America Clinical Trials

Please note while every effort has been made to insure the accuracy of the information provided, the links and other content herein should only serve as a basis for further investigation. Laws and regulations can change, and any American company interested in further researching overseas clinical trials should consult with their local Commerce office and the U.S. Embassy in the target country for further information. http://www.buyusa.gov/home/export.html

Pan American Health Organization (PAHO)

Flag of the Pan American Health Organization

The Pan American Health Organization (PAHO) is an international public health agency with more than 100 years of experience in working to improve health and living standards of the countries of the Americas. It serves as the specialized organization for health of the Inter-American System. It also serves as the Regional Office for the Americas of the World Health Organization and enjoys international recognition as part of the United Nations system.
http://new.paho.org/hq/index.php?lang=en

Argentina

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Clinical Research in Argentina: Pharmaceutical Industry Information http://www.pharmiweb.com/features/feature.asp?ROW_ID=672

ANMAT: National Administration for Food, Drugs and Technology http://www.anmat.gov.ar/
*Spanish only

Argentina Harmonizes Clinical Trial Regulatory Requirements to Conform with International Best Practices
http://www.drw-research.com/newsletter/Aug%2008.htm

Brazil

Flag of Brazil

Article Series from ClinPage
The second article describes changes in Brazils regulatory system.
1) A Quickening Process: Trials Thriving in Brazil
http://www.clinpage.com/article/trials_thriving_in_brazil/C15
2) Faster Launches: Brazil’s Regs
http://www.clinpage.com/article/brazils_regs/C15
3) IRBs Are Next: Brazil’s CRO Association http://www.clinpage.com/article/brazils_cro_association/C15
4) Profiling PPD & MMATISS: A Tale of Two CROs http://www.clinpage.com/article/a_tale_of_two_cros/C15

National Health Surveillance Agency (Anvisa)
http://www.anvisa.gov.br/eng/index.htm

Chile

Flag of Chile

Resources from CORFO, the Chilean Economic Development Agency

“An Emerging Location for Clinical Trials”: Brochure http://www.investchile.com/rps_corfo_v57/OpenSite/Investchile/Publications/Publications/carga/Chile,%20An%20Emerging%20Location%20For%20Clinical%20Trials.pdf
*Approval Timeframe: 30 days for evaluation and authorization by the Public Health Institute

Regulatory Organizations

  • Ministry of Health: Bioethical Unit
    The Ministry of Health Bioethical Unit reviews and authorizes all vaccination trials and clinical trials in which three or more Health Services participate.
    http://www.minsal.cl/
    *Spanish only
  • Scientific Ethics Committee of Health Service
    Reviews all clinical and vaccination trials that are conducted within its geographical area.
  • Clinical Trials Unit: Public Health Institute (ISP)
    Reviews and authorizes clinical trials which require entry into the country of non registered products.
    http://www.ispch.cl/
    *Spanish only

Temporary Entry to Chile Under the Chile-US Free Trade Agreement: A Guide for US Business Persons
http://www.chileusafta.com/manual%20entrada%20temporal.pdf

Mexico

Flag of Mexico

Secretariat of Health
http://portal.salud.gob.mx/index_eng.html

  • Federal Commission for the Protection against Sanitary Risk (COFEPRIS)
    The Federal Commission for the Protection against Sanitary Risk (COFEPRIS) is a decentralized organ of the Department of Health with technical, administrative and operational autonomy, whose mission is to protect the population against sanitary risks, through sanitary regulation, control and promotion under a single command, which provides unity and homogeneity to the policies which are determined.
    http://www.cofepris.gob.mx/wb/cfp/ingles

Reglamento de la Ley General de Salud en Materia de Investigacion para la Salud 1986
Regulation of the General Law of Health for Research on Health Related Topics
*text in Spanish
http://www.salud.gob.mx/unidades/cdi/nom/compi/rlgsmis.html

Puerto Rico

Flag of Puerto Rico

Under the Federal Food, Drug and Cosmetic Act, the Commonwealth of Puerto Rico is defined as a State and follows FDA regulations.
http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm

Pharmaceutical Industry Association of Puerto Rico
The Pharmaceutical Industry Association of Puerto Rico gathers and represents research-based multinational pharmaceutical and biotechnology companies with operations in Puerto Rico.
http://www.piapr.com/index.asp

North American Free Trade Agreement (NAFTA)

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North American Free Trade Agreement: Table of Contents
http://www.nafta-sec-alena.org/en/view.aspx?x=343&mtpiID=ALL#mtpi147

  • A NAFTA certificate of origin allows medical equipment to be imported duty-free.
    Look under Chapter 5: Customs Procedures, Part Two: Trade in Goods
  • NAFTA provides special conditions for the temporary entry of business persons into Mexico
    Look under Chapter Sixteen: Temporary Entry for Business Persons, Part Five: Investment, Service and Related Matters

Central America Free Trade Agreement (CAFTA)

Flag of CAFTA

United States-Dominican Republic-Central America Free Trade Agreement (CAFTA)
Historically, the United States has been the main trading partner of each of the countries in the agreement—Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, and Nicaragua. CAFTA has eliminated all tariffs on 80 percent of U.S. manufactured goods, with the remainder phased out over a few years. Importantly, the agreement is not limited to manufactured goods, but covers virtually every type of trade and commercial exchange between these countries and the United States. It also strengthens regulatory standards and environmental protections in Central America and the Dominican Republic and provides for independent, outside monitoring.
http://www.caftaintelligencecenter.com/subpages/What_is_CAFTA.asp