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Assessment of national regulatory authorities for medicines

The process of evaluation and assessment of NRAs is based on verification of the indicators included in the data collection tool. This instrument is based on the recommendations of the World Health Organization for strengthening the regulatory bodies.

The assessment of NRAs is based on fulfillment of critical indicators (46% of the indicators in the data collection tool). Four levels of development have been established. Level 4 is the level that enables PAHO to designate the regulatory body as a reference authority for medicines and biologicals.

Designation of the regional reference NRA is the responsibility of the regulatory authorities that reach level 4 of the assessment table.

Level 4: National regulatory authority that is competent and efficient in performance of the health regulation functions recommended by PAHO/WHO to guarantee the efficacy, safety, and quality of medicines. REGIONAL REFERENCE AUTHORITY.

Objectives and scope of a regional reference NRA

a) Participate in the quality assurance, safety, and efficacy processes for the products purchased by the Pan American Health Organization on behalf of the countries.

b) Collaborate as referents in the implementation and follow-up of recommendations approved by the PARF network.

c) Support the Pan American Health Organization in the strengthening activities for other national regulatory authorities in the Region, so that they can be designated as regional reference regulatory authorities.

d) Exchange public information through its Web sites and in the framework of the current national legislation on the products approved by the regional reference regulatory authorities. This will enable authorities with more limited capacities to have elements available for decision-making about their own products, considering that the products registered and sold in the countries with regional reference regulatory authorities will fulfill the quality standards recommended by WHO.

e) Establish mechanisms in agreement with the Pan American Health Organization that can favor the mutual recognition processes for the functions of the pharmaceutical regulatory bodies.

 

Documents:

icon Standarized evaluation procedure

icon Data collection tool

icon Evaluation orientation guide

Convocation of experts in NRA

The experts will be resources of the system for evaluation of national reference regulatory authorities and the system for prequalification of medicines. It is developed to:

  • Establish a transparent mechanism for selection of experts that participate in evaluation of the   NRAs  in accordance with the criteria established and shared by the countries of the region and approved by PAHO.
  • Form evaluation teams of the highest professional level to ensure standard development of the evaluations, yielding reliable and validated results.

Procedure for selection of experts

  • Presentation and reception of background information on the applicants. The reception date will be prior to the final day of February each year.
  • Review and evaluation of the background information. The background information and documents for the applicants will be evaluated in March each year.
  • Final report: Within the first 7 days of April a report will be sent to WHO, the regional offices, and the national regulatory authorities of the Region of the Americas making known the list of PAHO advisory experts in the area of regulation of medicines. An updated list will also be maintained on the PAHO Web site.

Documents:

Results of the assessment

Level 4 National regulatory authority that is competent and efficient in performance of the health regulation functions recommended by PAHO/WHO in order to guarantee the safety, efficacy, and quality of medicines. Regional reference authority.


Level 3 National regulatory authority that is competent and efficient, which shall improve performance of certain health regulation functions recommended by PAHO/WHO in order to guarantee the safety, efficacy, and quality of medicines.

 

Level 2 Structures or organizations with the mandate of the national regulatory authority that fulfill certain health regulation functions recommended by PAHO/WHO in order to guarantee the safety, efficacy, and quality of medicines.

 

Level 1 Offices of health institutions that fulfill certain health regulation functions for medicines.

 

EVALUATION

Country

Autoridad Reguladora Nacional

Level

Argentina

ANMAT. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

 

Level  4

December 2009

Brazil

ANVISA. Agencia Nacional de Vigilancia Sanitaria. Ministério da Saúde

 

Level 4 

May 2010

Chile


ISP de Chile, Instituto de Salud Pública

Level 3

August 2009

Cuba

CECMED, Centro para el Control Estatal de la Calidad de los Medicamentos. Ministerio de Salud Pública

 

Level 4

July 2010

Colombia

INVIMA, Instituto Nacional de Vigilancia de Medicamentos y Alimentos

 

Level  4

July 2010

Mexico

COFEPRIS, Comisión Federal para la Protección contra Riesgos Sanitarios

Level 4

June 2012

PRE-EVALUATION

Country

National Regulatory Authority

Bolivia 

UNIMED, Unidad de Medicamentos y Tecnologías de la Salud 

2009  

Ecuador

 

Instituto Nacional de Higiene y Medicina Tropical "Leopoldo Izquieta Pérez".
Ministerio de Salud

April 2009

El Salvador

 

Ministerio de Salud
Consejo Superior de Salud Pública

 

August 2010

Guatemala

 

Departamento de Regulación y Control de Productos Farmacéuticos y Afines

 

August 2010

Paraguay

 

Dirección Nacional de Vigilancia Sanitaria

July 2010

Dominican Republic 

 

Dirección General de Drogas y Farmacia


July 2010

Costa Rica

 

Dirección General de Salud/Universidad/Caja Costarricense del Seguro Social

July 2011

Honduras

Secretaría de Salud/Dirección General de Regulación Sanitaria

August 2011

Panama 

Dirección de Drogas y Farmacia

 

2011

Trinidad y Tobago

Autoridad Reguladora Nacional

 

2011

Jamaica

División de Estandarización y Regulación

 

2013

Suriname


Autoridad Reguladora Nacional 



2013


Guyana

 

Autoridad Reguladora Nacional

2013

Peru 

DIGEMID, Dirección General de Medicamentos, Insumos y Drogas

 

September 2013

Venezuela 

IHRR, Instituto Nacional de Higiene Rafael Rangel 

October 2013 

 

Presentation:Strengthening the National Regulatory Authorities (José Peña)

icon Results of the evaluation system

 

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