Pan American Health
Organization
An Overview of
Regulatory Harmonization Initiatives,
Regulatory Networks and Collaboration
In
Latin America and the Caribbean
James Fitzgerald (fitzgerj@paho.org)
Coordinator, Medicines and Health Technologies
PAHO/WHO Washington
Overview
 The Pan American Network for Drug Regulatory Harmonization;
 Strengthening National Regulatory Authorities for Medicines and
Biologicals in the Region of the Americas.
 Trends in LAC in Regional Cooperation and Collaboration
 Perspectives for Regulatory Harmonization and Convergence
Pan American
Health
Organization
The PANDRH Network in the
Americas
•
Pan American Network for Drug Regulatory Harmonization: established by
the Pan American Health Organization (PAHO) 42nd Directing Council
(2000) by Member States (CD42.R11):
•
Promotion of ‘technical agreements on drug regulation among the Member
States, including multilateral, bilateral, and subregional agreements, with
the participation of all sectors and interest groups’;
•
Prioritization in regulatory harmonization processes; promotion of technical
cooperation between NMRAs
 The components of PANDRH are:



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The Pan American Conference;
The Steering Committee;
The technical Working Groups in priority areas;
The Secretariat (PAHO).
Pan American
Health
Organization
PANDRH Governance
Regulators
Andean Area
CARICOM
MERCOSUR
SICA
NAFTA
INDUSTRY
Consumers
Academia
Professional
Associations
Pan American
Health
Organization
Pan American
Conference
Secretariat
Steering Committee
WG
WG WG
WG
WG WG
PANDRH Guidelines (2000 - 2010)
Pan American
Health
Organization
2011
VI PANDHR Conference
Brazil, 2011.
 Working Group Documents adopted:
– Recommendations for the evaluation of similar bio-therapeutic
products (SBP);
– Guidelines to be considered by the Health Authorities in the case of
suspected counterfeiting of medicines and medical products;
– Guidelines for the Registration of Medicines in the Americas;
– Guidelines for Good Clinical Practices;
– Guidelines for Clinical Trials in Pediatrics;
– Considerations on the Use of Placebo;
– Ethical criteria for the Promotion, Advertising, and Publicity of
Medicines.
Pan American
Health
Organization
2011
Adopt, Adapt and Implement
….. Impact
 Harmonized technical documents developed by the network
constitute normative reference for NMRAS in LAC;
– GLP (Technical Document 6): 21 countries have implemented the
guidelines
– Pharmacovigilance (Technical Document 5): 20 countries have adapted
norms based on ‘Documento de las Américas’.
– Vaccine CTD (Technical Document 1): partial implementation in 14 (of 17
countries investigated) with 7 countries reporting implementation;
 Technical Guidelines facilitate capacity building and
development of Regulatory Networks:
– GLP: Regional Network of 25 OMCLS from 23 countries;
– Pharmacovigilance: Network of Focal Points within NMRAs in the Americas
(12 countries);
– Vaccine CTD: guides technical support at country level
Pan American
Health
Organization
Increasingly Complex Integration
Systems
NAFTA
MERCOSUR
SICA
ANDEAN COMMUNITY
CARICOM
UNASUR
ALBA: ANT, BOL, CUB, DOM, ECU
NIC, STV, VEN
APEC
BILATERAL & MULTILATERAL
AGREEMENTS
REGIONAL & INTERREGIONAL
AGREEMENTS
Development of Regulatory Capacity to
support Regulatory Convergence
 Strengthening the regulatory capacity of the health authority as part of the
essential public health functions.
 In 2007, Latin American regulators and PAHO identified the need to
establish a transparent and uniform methodology to assess the functionality
of Regulatory Authorities.
 In June 2010 during the Executive Committee of PAHO, the Member States
requested the issue to be discussed within Directing Council of PAHO.
 In October 2010, the Directing Council of PAHO held a discussion on the
subject and as a result the Member States approved by consensus
Resolution CD50.R9 “Strengthening National Regulatory Authorities for
Medicines and Biologicals.”
Pan American
Health
Organization
Strengthening Regulatory
Authorities in Medicines and
Biologicals (CD50.R9), 2010.
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) to support the work of the Pan American Network for Drug Regulatory
Harmonization.
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;……
d) promote technical cooperation among country regulatory authorities as well as
recognition of the existing capacity in the Region;……
Region-wide Commitment to Strengthen
Regulatory Capacity
• Institutional development plans in process for:
Costa Rica, Chile, Dominican Republic, Ecuador, El Salvador,
Guatemala, Honduras, Panama, Paraguay, Trinidad & Tobago.
• 5 regulatory authorities in Latin America considered to be
National Regulatory Authorities of Regional Reference
(PAHO):
Argentina, Brazil, Colombia, Cuba, and Mexico;
• Argentina, Brazil, Colombia, Cuba (2011), Mexico (2012):
• To share GMP inspection reports, information on product recalls,
schedules for inspections;
• Working towards concession of GMP certificates based on inspections
from partner NMRAs.
Cooperation and Collaboration in LAC
•
Increasing bilateral regional
agreements (examples);
•
•
•
•
•
•
Brazil (Anvisa);13 bilateral;
Chile (ISP) 4 bilateral;
Mexico (COFEPRIS) 5 bilateral;
Medical Device Inspection Reports
(Brazil with US and Canada)
CARICOM / PAHO / US FDA; FOAR
(Argentina); strengthening
regulatory systems in the
Caribbean.
Recognition processes developing;
– eg Central America / Union Aduana;
– Ecuador, El Salvador: MNRAs of
PAHO Regional Reference
• ALBA, towards a Regional Center
and Single Registry for Medicines
Population 2008
(in 000’s)
9.638-1,000
1,000-5,000
5,000-30,000
30,000-100,000
100,000-308,798
A regional platform to facilitate convergence processes:
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•
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Launched May 2012 by PAHO/WHO, with support from US FDA and Brazil.
Collaborative and secure spaces for NMRAs to work together:
Communities of practice in regulatory capacity development, PANDHR Working
Groups;
Indicators presenting characteristics of national regulatory systems in 8
countries (in process);
Projects in development through the platform:
•
•
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PANDHR Strategic Development Plan 2013 – 2020;
Regulatory Workforce Development (IOM / FDA)
GMP Inspector Network
www/paho.org/prais
Considerations and Perspectives
•
Regulatory harmonization depends on political, economic and trade
agreements as well as policies within regional integration mechanisms;
•
Implementation of harmonized norms requires functional regulatory
systems;
•
Promoting NMRA partnerships and regulatory networks to develop joint
programs of work (convergence) is achievable in the short-mid term.
•
The use of modern technologies and technology platforms to facilitate
regulatory exchange, in secure environments, between regulators on key
issues facilitates convergence;
•
The PANDHR Strategic Development Plan (2013 – 2020) will focus on Good
Regulatory Practices, development of regulatory networks and regulatory
convergence of norms and processes.
•
VII PANDHR Conference to be hosted by Health Canada, 2013.