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2010
Quality and Regulation of Medicines and Health Technologies:Medicines and Health Technologies:
PAHO Update:
3rd Annual DIA Latin American Regulatory Conference, Panamá, April , 2010
José Peña Ruz Regional Advisor, Medicines and Health Technologies
PAHO/WHO
Content:
• Outcomes of the V Pan American Conference for Drug RegulatoryOutcomes of the V Pan American Conference for Drug RegulatoryHarmonization (PANDRH), Buenos Aires, November 2008.
• Update from Selected PANDRH Working Groups
• Adoption of Resolution CD50.R9 (2010) by the PAHO DirectingCouncil: Strengthening Regulatory Authorities for Medicines andBiologics.
• Increasing Regional Integration and Cooperation
• Perpsectives for 2010 - 2012
PANDRH, Pan American Drug Regulatory HarmonizationHarmonization
1. The PANDRH is an initiative of Regional meetings to discuss and look for solutions to common problems about leadership of the NRAs and the participation of several key actors; industry, academy and groups of interestinterest.
2. Stablish priorities in processes of drug harmonization and strengthen cooperation systems and convergence among member countries.
3. Promote the technical cooperation among the most developped NRAs and share experiences and knowledge with the less strengthened
4. Impulse the qualification of the NRA of the region according to stablished4. Impulse the qualification of the NRA of the region according to stablished criterion of the PAHO/WHO, in order to configure the reference of NRA and that can contribute actively with other objectives.
Pan American Drug Regulatory Harmonization Network
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Regulators of member C t i f
Panamerican ConferenceFor the Drug Regulatory
PARTICIPANTS
Countries of PAHO/WHO
Associations of Ph ti l i d t
Harmonization
Pharmaceutical industry•Innovatives and generic
SecretariatPAHO/WHO
Economic GroupsComunidad Andina
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Steering Committee
Comunidad AndinaCARICOMMERCOSUR NAFTA
WG WG WG
Consumers GroupsAcademyAssociation of professionals
SICA
Association of professionalsHarmonization initiatives
Focal Point
Steering Committee 2009 - 2011Steering Committee 2009 - 2011
NRA Head Members Alternate
NAFTA: USA CanadaSICA: Panama El SalvadorCAR: Trinidad &Tobago BarbadosMER: Argentina ChileCANDINA: Peru Venezuela
Industry FIFARMA and ALIFAR
Objectives of the Work Groupj p
• Conduct comparatives studies, identifying differences among legislations and practices among member countries;
P l f f l ti th t f ilit t th i l d• Proposal of formulations that facilitate the regional drug regulation harmonization;
D fi l t i th ti• Define plan to improve the cooperation among countries;
• Support the NRA in the process of implementation and• Support the NRA in the process of implementation and disemination of scientific knowledge;
WG Members by Organization
23%23%
3%NRANRAINDUSTRYOthers
74%
Working Groups
1. GMP2. BE/BD3 GCP3. GCP 4. Counterfeit / Falsification of
Medicines5 Classification5. Classification6. Marketing Authorization7. Pharmacopeas8 Medicinal Plants8. Medicinal Plants9. Pharmacovigilance10. Vaccines11 GLP11. GLP12. Promotion marketing13. Biological/Biotechnological
V PANDRH Conference, Argentina, 17-19 November 2008
• Presentation and Introduction by Director PAHO/WHOby Director PAHO/WHO, Americas and Director of ANMAT, Argentina;
• >250 participants NRAs• >250 participants, NRAs, Industry, Academia, accredited PAHO/WHO NGOs;
• Keynote Presentations Panel
NAFTA
MERCOSUR
• Keynote Presentations, Panel Presentations, WG Discussions, Conference meeting and adoption of harmonized technical MERCOSUR
SICAANDEAN COMMUNITYCARICOM
documents.
Principle Themes of V Conference
• Pharmaceutical Regulation and Public Health (PAHO/WHO and ANMAT Argentina)
• Update on Drug Regulatory Harmonization Initiatives– ICDRA, ICH, PANDRH and ASEAN Initiatives
• System for Inter-ARN Recognition (PAHO/WHO & CECMED (Cuba))– Adoption of a transparent and uniform methodology for evaluating ARN core
functions;
• Counterfeiting as a Public Health Problem (WHO)– Update on global and regional activities with discussion on definition.
• WHO Prequalification (WHO)– Presentation of scope, process and technical documentation
• Rational Use as a Component in Regulatory Decisions (CC/PAHO)– Regulation of information on use of medicines, monitoring of marketing of medicines
Technical Documents Adopted (8)
• BE: Framework for Implementation of Equivalence Requirements for Pharmaceutical Products*
• PV: Good Pharmacovigilance Practices*
• Vaccines: Harmonized Requirements for the Registration of Vaccines in the Regional of the Americas
• Vaccines: Guidelines for Preparation of a request forVaccines: Guidelines for Preparation of a request for registration.
• GCP: Guide for conducting clinical studies in pediatric populations*
• GMP: Decision tree for the Implementation of the Guidelines for Good Manufacturing Practices Inspection
• GMP: Good Manufacturing Practices for Pharmaceutical Ingredients (ICH-Q7)g ( )
• GMP: Code of Ethics for Inspectors of Good Manufacturing Practices
* with changes suggested by the Conference
Update from selected PANDRH WGs (1)
• Biotechnological Products: – Creation of a PANDRH technical working group on biotechnological products– Regional meeting on regulation of biotechnological products and First meeting of the PANDRH
biotechnological products working group [June 2010, Dominican Republic]– Members: ARG, BRA, PER, GUT, T&T, BAR, CAN, CUB, VEN, FIFARMA, ALIFAR
• Vaccines– Development of the Plan of Work to monitor implementation of Harmonized Guidelines for
Registration.
• Pharmacovigilance:Pharmacovigilance:– Good Pharmacovigilance Practices for the Americas. Validated by Colombia. Adopted by subregional
groups: the Andean Region and individual countries (Colombia, Argentina).– Virtual Training of 20 representatives from seven countries. Next scheduled course 2011.
• Counterfeit / Falsification of Medicines:– Workshop for Prevention and Combat of Counterfeit Medicines: “Establishing an inter-sectorial
partnership and a plan of action”.– Panama, Bolivia, Jamaica / OECS: Plan of work, revision of legislation, task force.
U d d l t I ti id li d N t k f F l P i t– Under development: Inspection guidelines and Network of Focal Points
Update from selected PANDRH WGs (2)
• Good Clinical Practices:– Considerations of Use of Placebo
Investigators brochure– Investigators brochure– Clinical Trials on pediatric population
• Good Laboratory Practices:– GLP workshops in Argentina and Panamap g– Workshop with ANVISA and LACEN, Brazil.– Support to OMCLs in the WHO External Quality Control Program
• Three Regional OMCLs achieve WHO Prequalification as Reference Quality Control Laboratories for the United Nations (Sep 2010)United Nations (Sep 2010).
– CONCAMYT (Official Laboratory for Toxicology and the Quality Control of Medicines), Bolivia.– CNCC (Official Laboratory, National Centre for Quality Control), Peru.– CCCM (Official Laboratory, The Commission for the Quality Control of Medicines) Uruguay– All labs are certified ISO 9001 and /or ISO 17025 and have been active participants in the
PAHO/WHO external quality programs.
2011
VI Conference of the Pan American Network on Drug Regulatory Harmonization (PANDHR)Regulatory Harmonization (PANDHR)
Strengthening of the National Regulatory Authoritiesin the context of Health Systems
Brasilia, Brazil 6-8 July 2011
AGENDA• Publication of Articles, NRAs• Work GroupsWork Groups• Conferences• Round tables
OrganizaciónPanamericanaDe la Salud JPR/MT/HHS
Components of national system that guarantees quality Components of national system that guarantees quality medicationmedicationmedicationmedication
• Producers
• National Regulatory Authorities (NRAs), independent and competent
• Users
Strengthening Regulatory Authorities in Medicines and Biologics (CD50.R9), 2010 (1).
– Latin American Regulators and PAHO/WHO identify need to establish a transparent and uniform methodology for evaluating NRA performance and p gy g pcore functions (2007);
– Initial participation of Latin American Regulators (7) with consensus on tool and indicators, Mexico, July 2008.
– Evaluation guide and SOPs for evaluation developed (2009).– Experts selected from regional and other reference NRAs (Spain, Portugal).– Assessments completed in Argentina, Brazil, Colombia, Chile, Cuba, and pre-p g p
assessments in the Dominican Republic, El Salvador, Guatemala, Paraguay (2010).
– Process: Virtual meetings between evaluation team and ARN, definition of agenda, signing of conflict of interest and confidentiality agreement, presentation of the assessment tool, pre-filling of the tool by the ARN, assessment by the evaluation team, discussion of results and development of work plan final reportof work plan, final report.
2010
Reference of Evaluaton of the NRAReference of Evaluaton of the NRATool module of data recollectionTool module of data recollection
12
General informationRegulatory System
3 N ti l R l t A th it3 National Regulatory Authority
4 Marketing authorization
5 Licensing of producers5 Licensing of producers
6 Market surveillance
7 Pharmacovigilance
8 Clinical Trial
9 Inspections and supervision activities
OrganizaciónPanamericanaDe la Salud JPR/HSS/MT
10 Quality laboratory control
Calification Results of the NRA
• Level IV: National Regulatory Authority competent and efficient in performing the functions of sanitary regulation recommended by the PAHO/WHO to guarantee the efficacyrecommended by the PAHO/WHO to guarantee the efficacy, safety and drug quality. AUTHORITY REFERENCE .
• Level III: National Regulatory Authority competent andLevel III: National Regulatory Authority competent and efficient that must perfect the performance in certain functions of sanitary regulations recommended by PAHO/WHO to guarantee the efficacy, safety and drug quality.
• Level II: Structures or organizations with mandate of National Regulatory Authority that fulfill certain functions of sanitary recommendations of PAHO/WHO to guarantee thesanitary recommendations of PAHO/WHO to guarantee the efficacy, safety and drug quality.
• Level I: Units of health institutions that fulfill determined functions of sanitary drug regulationy g g
Programming: 2009-2010:Evaluation: ARG-BRA-CHI-COL-
CUB-MEX-VENSelfevaluation: BOL-COR-GUT-NIC-
HON-ELS-PAN-DORPre evaluation: ECU-DOR-ELS-GUT
-PAR
Strengthening Regulatory Authorities in Medicines and Biologics (CD50.R9), 2010 (2).
– Anmat (Argentina), Brazil (Anvisa), Colombia (Invima) and Cuba (CECMED) classified as ARNs, Level IV, ‘….competent and(CECMED) classified as ARNs, Level IV, ….competent and efficient in the implementation of standards necessary to ensure the quality, safety and efficacy of medicines’.
– Member States at the PAHO Executive Committee request discussion of initiative within the Directing Council, PAHO, June 20102010.
– PAHO Directing Council takes up the discussion, Resolution adopted with endorsement of all Member States, and with 15 country interventions providing strong endorsement for the initiative.
Strengthening Regulatory Authorities in Medicines and Bi l i (CD50 R9) 2010 (3)Biologics (CD50.R9), 2010 (3).
To request Member States:a) strengthen and evaluate their regulatory capacity with respect to the functions
characteristic of a regulatory agency for medicines and biologicals, through an examination of the performance of their essential functions;
b) use the results of the qualification activity and the designation of the b) use t e esu ts o t e qua cat o act ty a d t e des g at o o t eregulatory authorities of regional reference to strengthen their performance in terms of the steering role of the health authority;…
To Request the Director:To Request the Director:a) support initiatives for the strengthening and qualification of national
regulatory authorities to guarantee the quality, safety, and efficacy of medicines, biologicals,and other health technologies;……
c) maintain and strengthen the collaboration of the Pan American Healthc) maintain and strengthen the collaboration of the Pan American Health Organization with the Member States in the area of medicines and biologicals regulation;
d) promote technical cooperation among country regulatory authorities as well as frecognition of the existing capacity in the Region;……
Project Conclusions
• Project of great impact at a country and region level.• Generate conditions for agreements between countries and region• Great motivation of the NRA personnel• Impact in process improvement• Motivation, learning and compromise of the selected experts.• Models and activities that can be an example in the Region:
SGC (Colombia)Import/Export (Chile)PHV (Cuba, Brasil y Colombia)Combat to falsification (Argentina Brazil)Combat to falsification (Argentina-Brazil)First lot of verification (Argentina)CT Inspections (Argentina)Web Site (Argentina)Bioequivalence (Brazil)Bioequivalence (Brazil)LNCC (Brazil)GMP Inspections overseas (Brazil)Social Participation (Brazil)
Increasing Regional Integration and Cooperation
– UNASUR: integration of South American countries, with a 5 year work plan in Access to Medicines adopted and in implementation
ALBA Boli ia C ba Dominica Ec ador Nicarag a Vene ela Project– ALBA: Bolivia, Cuba, Dominica, Ecuador, Nicaragua, Venezuela; Project ALBAMed focusing on common registration process for medicines used in public health programs.
CARICOM / WB / PAHO: Study on regulatory capacity and options in– CARICOM / WB / PAHO: Study on regulatory capacity and options in harmonization; recommendations incorporated into Regional Pharmaceutical Policy to be presented at COHSOD, April 2011.
– PAHO / ANVISA: Cooperative Agreement (2010 – 2015) to strengthenPAHO / ANVISA: Cooperative Agreement (2010 2015) to strengthen regulatory capacity, in particular in areas of HTA, regulation of the promotion of medicines, norms and standards in medicines.
– PAHO / FDA: Cooperative Agreement (2010 – 2014) on the development p g ( ) pof a virtual platform or regional hub to promote exchange of information between Member States on regulatory processes and functions.
– BID : Central America, assessments to determine opportunities for h i ti f h ti l l tiharmonization of pharmaceutical regulations.
Regional Platform : ObjectiveRegional Platform : Objective
• Create a platform composed by a series of virtual p p ytools to support and promote innovation, access, rational use and rectory in the medication area and essential and strategic sanitary technologies g y gfrom the perspective of public health and to attend the priorities of the health of the Region.
Acceso e Innovación Tecnológica:una nueva perspectiva
NecesidadesSociales
Innovación paraatender prioridadesImpacto Social atender prioridades
de salud
InvestigaciónCientífica
Acceso Innovación tecnológica paramedicamentos y tecnologías
sanitariasUna nueva perspectiva
DesarrollotecnológicoProductos
Una nueva perspectiva
Desarrollo de Productos
•Farmacovigilancia•Epidemiología
•Epidemiología•Diagnósticos•Perfiles de enfermedadT t i t
•Precios•Fuerzas de MercadoE í
•Bioinformática
•TratamientosNecesidades
SocialesInnovación para
atender prioridadesImpacto Social•Economía Farmacéutica
•Modelación de moléculas•Mapeo genómic•Análisis Químicos y
atender prioridadesde salud
•GPF•Control y garantía de
Químicos y Bioquímicos•Biología•Biotecnología
InvestigaciónCientífica
Mercado Innovación tecnológica paramedicamentos y tecnologías
sanitariasUna nueva perspectivag
Calidad•Bioingeniería Desarrollo
tecnológicoProductos
Una nueva perspectiva
•Ensayos preclínicos•Ensayos clínicosGCP
•Desarrollo Farmacéutico•Desarrollo Químico•Biotecnología
Desarrollo de Productos
•GCP•Toxicología•Farmacología
•Biotecnología•Tecnologías de administración
Origen: Plataforma Regional de Innovación y Acceso para la Salud[1].pdf
Ejemplo…
Uso Racional Y Oseltamivir
Datos Esenciales Participemos Mejoremos Profundicemos
Búsqueda:
•Estudios de utilización.I id i
•Comunidad dePráctica: Uso R i l
•Curso de Uso Racional de MedC d di
•Resúmenes deEvidencia sobre
ti i l•Incidencia H1N1/país
Racional •CoP ProducciónNacional de Med•Blog Gripe
•Curso de diag. Virológico rápi-do.
antivirales•Info pat y prodde Oseltamivir•Publicaciones g p
Respuesta RápidaPregunte: Respuesta RápidaPregunte:
Foro de innovación abierta
PROBLEMA/SOLUCIÓN
Perspectives for 2010 - 2012– Implementation of the Resolution CD50.R9 to Strengthen
National ARNs:• Integration of medicines and biologics / vaccines evaluations
with support from ARNs of regional reference;with support from ARNs of regional reference;• Using installed capacity to promote inter-NRA collaboration;
– Promoting exchange and links between NRAs networking to– Promoting exchange and links between NRAs, networking to ensure capacity building:
• Through PANDRH and its WGs, and implementation of regional cooperation projects with partners;
– Organization of VI PANDRH Conference, Brazil, July 2011.• A focus on health systems and regulatory capacity;• Consolidation of WGs and presentation of working
documents;
– Virtual platform development on drug regulation component
