An Overview of

Regulatory Harmonization Initiatives,

Regulatory Networks and Collaboration

In

Latin America and the Caribbean

Pan American Health Organization

James Fitzgerald (fitzgerj@paho.org)

Coordinator, Medicines and Health Technologies

PAHO/WHO Washington

Pan American Health Organization

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

Overview

• 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: The Pan American Conference; The Steering Committee; The technical Working Groups in priority areas; The Secretariat (PAHO).

Pan American Health Organization

The PANDRH Network in theAmericas

Consumers

Academia

Professional Associations

Pan American Conference

Secretariat

Steering Committee

WG WG

WG WG

WG

WG

RegulatorsAndean AreaCARICOMMERCOSURSICANAFTAINDUSTRY

PANDRH Governance

Pan American Health Organization

PANDRH Guidelines (2000 - 2010)

Pan American Health Organization

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

VI PANDHR ConferenceBrazil, 2011.

2011

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

Adopt, Adapt and Implement….. Impact

NAFTA

MERCOSURSICA

ANDEAN COMMUNITY

CARICOM

BILATERAL & MULTILATERAL AGREEMENTS

REGIONAL & INTERREGIONAL AGREEMENTS

ALBA: ANT, BOL, CUB, DOM, ECUNIC, STV, VEN

UNASUR

APEC

Increasingly Complex Integration Systems

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

Development of Regulatory Capacity to support Regulatory Convergence

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.

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

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

www/paho.org/prais

A regional platform to facilitate convergence processes:

• 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:

• PANDHR Strategic Development Plan 2013 – 2020;• Regulatory Workforce Development (IOM / FDA)• GMP Inspector Network

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.