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PAN AMERICAN NETWORK FOR DRUG REGULATORY HARMONIZATION. Mexico May, 2003 Steering Committee WG/GMP WG/D Classification. Rosario D’Alessio PAHO/WHO. DRUG REGULATORY HARMONIZATION FORUMS. International Conference on Drug Harmonization (ICH) European Agency on Drug Evaluation (EMEA)

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  1. PAN AMERICAN NETWORK FOR DRUG REGULATORY HARMONIZATION Mexico May, 2003 Steering Committee WG/GMP WG/D Classification Rosario D’Alessio PAHO/WHO

  2. DRUG REGULATORY HARMONIZATION FORUMS • International Conference on Drug Harmonization (ICH) • European Agency on Drug Evaluation (EMEA) • WHO International Conference of Drug Regulatory Authorities (ICDRA) • Subregional Economic Groups: • MERCOSUR - CARICOM - AA • NAFTA - CENTRAL AMERICA

  3. NAFTA MERCOSUR SICA ANDEAN COMMUNITY CARICOM Groups of Economic Integrationin the Region of the Americas

  4. HARMONIZATION Search for common ground within the framework of recognized standards, taking into account the different political, health, and legislative realities in the Americas Region

  5. I Pan American Conference on Drug Regulatory Harmonization NOV 1997 • Priority to health consideration in trade and economic integration processes • Support to ongoing harmonization process • Strengthening of regulatory agencies • Confidentiality of unpublished information • Establishment of a hemispheric forum: • Secretariat: PAHO • Steering Committee • All parties concerned with pharmaceuticals • Financial support provided by industry and governments

  6. II Pan American Conference on Drug Regulatory HarmonizationNOV 1999 • Advances in Drug Regulation • Results from WGs on BE and GCP • GMP key subject to be enforced • Counterfeit drugs • Drug classification • Establishment of the Pan American Network for Drud Regulatory Harmonization

  7. III Pan American Conference on Drug Regulatory HarmonizationAPRIL 2002 • Update on ICDRA, FTA, MERCOSUR, AA, CIECA in Drug Regulatory Harmonization • Impact of ICH in ud countries • WHO prequalification project • Helsinky and Clinical Trials w/ active Controls • Counterfeit drugs: case study • Promotion & Sale of Drugs through Internet • Group Report: GMP; BE; GCP; Counterfeit; Farmacopoeia & EQC; • Preliminary report on Regulatory Agencies Studies

  8. Pan American Network forDrug Regulatory Harmonization

  9. PAN AMERICAN CONFERENCE ON DRH Objectives: 1. To identify global harmonization issues and their relevance to the region; 2. To identify the stage of development in the current sub-regional group; 3. To identify common obstacles and/or problems; 4. To recommend subjects, strategies and actions to facilitate hemispheric DRH.

  10. MISSION CONFERENCE STEERING COMMITTEE The Conference should promote drug regulatory harmonization for all aspects of quality, safety and efficacy of pharmaceutical products as a contribution to the quality of life and health care of the citizens of the Member Countries of the Americas. The Steering Committee should enable progress between Conferences by coordinating, promoting, facilitating and monitoring harmonization processes in the Americas.

  11. GOALS Conference Steering Committee • To examine regulatory systems • To develop and adopt proposals for technical regulatory harmonization • To review existing regulatory requirements and guidelines for specific issues • To identify and discuss medicinal regulation implementation issues • Identify experts to ensure effectiveness and relevance of the conference • To develop/maintain an information system to disseminate advancements on harmonization • To identify mechanisms for fostering capacity building and technical & scientific cooperation • To provide information on regulatory systems

  12. OBJECTIVES Conference Steering Committee • Dialogue among participants at the conferences • Adopt recommendations • Encourage convergence of drug regulatory systems • Encourage and facilitate technical cooperation • Promote harmonization • Ensure effectiveness and relevance of the conference • Monitor implementation of conference • recommendations • Ensure continuity • Facilitate consensus - building and resolution of issues

  13. OPERATION CONFERENCE STEERING COMMITTEE 1. To organize meetings, workshops, to carry out recommendations of the Conference. 2.To establish study groups on regulatory topics identified by the Conference as more relevant. 3. To determine preparatory activities necessary for subsequent Conferences. 4.To determine the best methods to resolve issues and reach consensus. 5. To convene meetings at which a quorum of two thirds of the membership are present. 1.To promote participation by all interested parties in the Americas and those invited by the S C. 2.To be held every two years at a date and place determined by the Steering Committee. 3.To adopt all Conference recommendations and conclusions by consensus in plenary sessions. If consensus can not be reached, the different points of view will be recorded.

  14. FINANCING SOURCES • Pharmaceutical Industry Associations • Professional Associations • Governments • Conference Registration Fees • Non Governmental Organizations • Pan American Health Organization • others

  15. SECRETARIAT • 1. The Secretariat of the Network, the Conference and the Steering Committee will be provided by PAHO • 2. The Secretariat shall: • Provide administrative and technical support • Coordinate actions deriving from recommendations • Act as a clearinghouse for information • Arrange for expert advice and consultants • Act asliaison, with similar programs such as ICDRA, ICH and other national or regional trade agencies, and others as necessary, • Maintain permanent communication will the SC • Seek financial support

  16. Steering Committee2002-2004 • 5 Regulatory Authorities Members Alternate • Mexico * USA • Guatemala * Costa Rica • Jamaica * Trinidad &Tobago • Brazil * Argentina • Colombia * Bolivia • One rep from FIFARMA ------------- • One rep from ALIFAR ------------- • NGOs related to pharmaceuticals in official relations with PAHO can participate as OBSERVERS at SC’ meetings

  17. Pan American Network for DRH Working Groups 1. Good Manufacturing Practices 2. Bioequivalence and Bioavailability 3. Good Clinical Practices 4. Classification of Products 5. Counterfeit Drugs 6. Pharmacopoeia 7. Medicinal Plants 8. Farmacovigilance 9. Drug Registration

  18. FROM THE III PAN CONF (May 2002- May 2003) • III Pan American Conference • GMP National Seminars • Conclusion of Special Studies on DRA • WEB page • WG/GCP Meeting • WG/BE • Regional TRM & WG/Medicinal Plants • WG/ GMp, D Class % SC

  19. FROM NOW UNTIL THE IV PAN CONFERENCE • Two (or 3) set of meetings for all WGs • ONE SC meeting: to review WG development & agenda for the IV Conference • Educational Seminars: • Two GCP • Two BE • Six GMP

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