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: (only in Spanish)
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.
- Selection process for PAHO experts for evaluation of the national regulatory authorities
- Application form for national expert on national regulatory authority for medicines
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.
Regional Reference Authorities for medicines CD50.R9 (January, 2018)
- Argentina ANMAT. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
- Brazil ANVISA. Agencia Nacional de Vigilancia Sanitaria. Ministério da Saúde
- Canada HS - Health Canada
- Chile ISP, Instituto de Salud Pública
- Colombia INVIMA - Instituto Nacional de Vigilancia de Medicamentos y Alimentos
- Cuba CECMED, Centro para el Control Estatal de la Calidad de los Medicamentos.Ministerio de Salud Pública
- Mexico COFEPRIS, Comisión Federal para la Protección contra Riesgos Sanitarios
- United States of America USFDA - Food and Drug Administration
National Regulatory Systems for Medicines in The Americas. Evaluation and Pre-evaluation - CD50.R9 (January, 2018)
Country, Institution and (Year)
- Argentina ANMAT. Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (2017)
- Bahamas BNDA - Bahamas National Drug Agency (2017)
- Barbados BDS - Barbados Drug Service (2015)
- Bolivia UNIMED, Unidad de Medicamentos y Tecnologías de la Salud (2009)
- Brazil ANVISA. Agencia Nacional de Vigilancia Sanitaria. Ministério da Saúde (2017)
- Canada HC - Health Canada (2015)
- Chile ISP - Instituto de Salud Pública (2016)
- Colombia INVIMA - Instituto Nacional de Vigilancia de Medicamentos y Alimentos (2017)
- Costa Rica Dirección General de Salud/Universidad/Caja Costarricense del Seguro Social (2011)
- Cuba CECMED - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (2017)
- Dominican Republic Dirección General de Drogas y Farmacia (2011)
- Ecuador Instituto Nacional de Higiene y Medicina Tropical "Leopoldo Izquieta Pérez". Ministerio de Salud (2017)
- El Salvador Dirección Nacional de Medicamentos (2017)
- Guatemala Departamento de Regulación y Control de Productos Farmacéuticos y Afines (2010)
- Guyana FDD - Food and Drug Department (2013)
- Haiti DNM/MT - Direction de la Pharmacie, du Médicament et de la Médecine Traditionnelle (2017)
- Honduras Secretaría de Salud/Dirección General de Regulación Sanitaria (2011)
- Jamaica DSR - División de Estandarización y Regulación (2013)
- Mexico COFEPRIS - Comisión Federal para la Protección contra Riesgos Sanitarios (2017)
- Panama Dirección de Drogas y Farmacia (2011)
- Paraguay Dirección Nacional de Vigilancia Sanitaria (2016)
- Peru DIGEMID, Dirección General de Medicamentos, Insumos y Drogas (2013)
- Suriname Autoridad Reguladora Nacional (2013)
- Trinidad and Tobago Autoridad Reguladora Nacional (2011)
- United States of America USFDA - Food and Drug Administration (2016
- Venezuela IHRR, Instituto Nacional de Higiene Rafael Rangel(2013)
Presentation:Strengthening the National Regulatory Authorities (José Peña) (only in Spanish)