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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.



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.


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.




Autoridad Reguladora Nacional



ANMAT. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica


Level  4

December 2009


ANVISA. Agencia Nacional de Vigilancia Sanitaria. Ministério da Saúde


Level 4 

May 2010


ISP de Chile, Instituto de Salud Pública

Level 3

August 2009


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


Level 4

July 2010


INVIMA, Instituto Nacional de Vigilancia de Medicamentos y Alimentos


Level  4

July 2010


COFEPRIS, Comisión Federal para la Protección contra Riesgos Sanitarios

Level 4

June 2012



National Regulatory Authority


UNIMED, Unidad de Medicamentos y Tecnologías de la Salud 




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



Departamento de Regulación y Control de Productos Farmacéuticos y Afines


August 2010



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


Secretaría de Salud/Dirección General de Regulación Sanitaria

August 2011


Dirección de Drogas y Farmacia



Trinidad y Tobago

Autoridad Reguladora Nacional




División de Estandarización y Regulación




Autoridad Reguladora Nacional 




Autoridad Reguladora Nacional



DIGEMID, Dirección General de Medicamentos, Insumos y Drogas


September 2013


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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