PANDRH: Documents and publications

Since PANDRH was stablished, it has produced documents pursuant to PAHO Resolutions and based on the needs of the countries of the Americas, supporting regional technical cooperation initiatives to strengthen national regulatory capacities.

Main PANDRH' documents and PAHO/WHO Resolutions

• Statutes of the Pan American Network for Drug Regulatory Harmonization Approved Dec. 2015 [English - Spanish]
• Terms. Procedure for the Prioritization of Areas and Selection of Projects. PANDRH [2015] [English - Spanish]
• VII CPANDRH Conference Report  [English - Spanish]
• PANDRH Strategic Development Plan 2014 - 2020 [English - Spanish]
• 42nd Directing Council. Washington, D.C., 25-29 September 2000. Provisional Agenda Item 4.9 CD42/13, Rev. 1 (Eng.) 13 September 2000. Pharmaceutical Regulatory Harmonization in The Americas. [English - Spanish]
• 42nd Directing Council. Washington, D.C., 25-29 September 2000. Resolution CD42.R11. Drug Regulatory Harmonization [English - Spanish]

Steering Committee Members and Minutes

• pdf Meeting: Steering Committee of the Pan American Network for Drug Regulatory Harmonization (PANDRH). 19th and 20th October 2016
• pdf Aide-Memoire. PANDRH Steering Committee virtual meeting. May 2nd, 2016
• Aide-Memoire. Virtual Meeting of the Steering Committee of the Pan American Network for Drug Regulatory Harmonization (PANDRH) December 16, 2015
• Aide-Memoire. Meeting of the Steering Committee of the Pan American Network for Drug Regulatory Harmonization (PANDRH). Washington,D.C. 27 and 28 May 2015
• Executive Summary- PANDRH Steering Committe. November 2011
• Act of the Steering Committe of PANDRH, October, 2010. Santiago, Chile.
  • Annex 2. Proposed Terms of Reference. VI Conference of PANDRH. (Brasilia, July 2011)
  • Annex 3. Instruccions to authors of manuscripts
• Virtual Meeting. April, 2010
• Virtual Meeting. January, 2010
• Washington, D.C. June, 2006
• Santo Domingo, Dominican Republic. March, 2005
• Washington, D.C. December, 2004
• Madrid, Spain. February, 2004(Annex 1 - Annex 2 - Annex 3)
• Mexico City, Mexico. May, 2003. (Annex 1 - Annex 2 - Annex 3 - Annex 4 - Annex5 - Annex 6 - Annex 7 - Annex 8 - Annex 9)
• Orlando Florida. March, 2001(Annex 1 - Annex 2 - Annex 3 - Annex 4)
• Caracas, Venezuela. January, 1999
• Member list of the Technical Working Groups. 2010. [English - Spanish]
• Report from the Secretariat 1997 - 2005. Pan American Network for Drug Regulatory Harmonization. An Overview

Historic documents

PANDRH Technical Working Groups

They are groups of experts in areas that have been identified as priorities for the drug regulatory harmonization. Members are selected by the Steering Committee and confirmed by the regulatory authorities of the respective countries. Whenever possible, WG should have at least one representative for each of the five sub-regional blocs of the Americas.

Academics and other experts can be members of the WG. Its main objectives include the implementation of diagnostic studies in order to identify the differences among the countries regarding the implementation of internationals standards and to define the necessary strategies for technical cooperation; analyze international guidelines and prepare harmonized proposal in their areas to be considered for the conference for its implementation in the region.

• Objectives, members, presentations and publications of each Working Group is availabe in [English  - Spanish]
• Member list of the Technical Working Groups [English - Spanish]
• Pre Conference PANDRH. Evaluation of multi source pharmaceutical products. Special Focus on Anti Retroviral Drugs - Washington, D.C., April, 2003  [English]
• Normas farmacológicas [Spanish]
• Subregional Meeting August - 2005. Regulatory Authorities of Central Ame rica, Cuba and Dominican Republic [Spanish]
• Propuesta de actualización. 17 de noviembre de 2008  [Spanish]

Publications PANDRH Working Groups

During its existence, the TWG have contributed to the dissemination of technical knowledge consistent with the pharmaceutical regulatory harmonization in the Region of the Americas. These works, in major publications, are available in English, Spanish, and Portuguese. Some publications are material for historical reference because they have been updated or are in the process of being revised.

• Regulatory reliance principles: concept note and recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH)(San Salvador, 24 to 26 October, 2018). PANDRH 2019 (PAHO/HSS/19-003). Available in Spanish and English
• Regulation of Advanced Therapy Medicinal Products: Concept Note and Recommendations. Ninth Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). (San Salvador, October 2018. Available inSpanish and English.

• PANDRH Network Technical Document No. 1 . Harmonized requirements for the licensing of vaccines in the Americas and Guidelines for preparation of application. (2010) 40 p. (In Spanish -  English - Francés )

• Red PARF Documento Técnico No. 2. OMS Serie de Informes Técnicos, No. 902, 2002. Informe 36, Anexo 3. Buenas prácticas para Laboratorios Nacionales de Control Farmacéutico. (2010) 137 p.(Publication in three languages: Spanish, English, and Portuguese

• Red PARF Documento Técnico No. 3. Guía de autoevaluación de buenas prácticas para Laboratorios Nacionales de Control Farmacéutico. (2010) 71 p. (Publication in three languages: Spanish, English, and Portuguese)

• Red PARF Documento Técnico No. 4. Estudio sobre las condiciones actuales de los Laboratorios Oficiales de Control de Calidad de Medicamentos (LOCM) en América Latina y el Caribe. (2010) 45 p.(Publication in three languages: Spanish, English and Portuguese)

• PANDRH Network Technical Document No. 5. Good Pharmacovigilance Practices for the Americas (2011) 83 p. (In Spanish - English - Portuguese)

• Red PARF Documento Técnico No. 6. Documento de Autoevaluación de Buenas Prácticas de Laboratorio (BPL) (2011) 113 p.  (Publication in three languages: Spanish, English y Portuguese)

• Red PARF Documento Técnico No. 7. Recomendaciones para la Evaluación de Productos Bioterapéuticos Similares (PBS) (2011) 82 p. ( pdf Publication in two languages: Spanish, and Portuguese )

• PANDRH Technical Report Nº 8. Framework for Implementation of Equivalence Requirements for Pharmaceutical Products (2011) 38 p. (In Spanish and English)

• Rede PARF Documento Técnico No. 9. Boas Práticas da OMS para Laboratórios de Controle de Qualidade de Produtos Farmacêuticos (2011) 58. (In Portuguese)  

• PANDRH Technical Report No 10. Requirements for Medicines Registration in the Americas (2013) 42 p. (In Spanish and English)
• Red PARF Documento Técnico No 12. Criterios éticos para la promoción, propaganda y publicidad de medicamentos (2013) 16 p.(In Spanish)

Conferences: Minutes and Conclusions

• VIII CPANDRH Documents [Mexico, 2016]
• VII CPANDRH Conference Report
• VII PANDRH Technical Working Groups Operations Report
• VI Conference of the Pan American Network for Drug Regulatory Harmonization. Brasília, Brasil, 6-8 July, 2011.
• V Conference of the Pan American Network for Drug Regulatory Harmonization. Working Documents. Buenos Aires, Argentina. 16-18 November, 2008.
• IV Conference of the Pan American Network for Drug Regulatory Harmonization. Conclusion. Dominican Republic, 2 - 4 March, 2005 and Minutes.
• III Conference of the Pan American Network for Drug Regulatory Harmonization. Final Report. Washington, D.C., 24-26 April, 2002.
• II Conference of the Pan American Network for Drug Regulatory Harmonization. Conclusion. Washington, D.C., 2-5, November, 1999.
• I Conference of the Pan American Network for Drug Regulatory Harmonization. Conclusion. Washington, D.C., 18-20 November, 1997.