Publication: Análisis retrospectivo de las deficiencias de calidad encontradas en los master files de ingredientes activos farmacéuticos para la precalificación de medicamentos por la Organización Mundial de la Salud
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2017-07-17
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Universidad Complutense de Madrid
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Abstract
Una regulación adecuada de los medicamentos, como la que existe en los países desarrollados, permite garantizar que los productos que llegan al paciente tengan una calidad, seguridad y eficacia adecuadas, así como una información correcta. En los países en desarrollo estos sistemas de regulación son limitados, por lo que son habituales los problemas de calidad en los medicamentos. El Equipo de Precalificación de Medicamentos (PQTm) de la Organización Mundial de la Salud (OMS) se encarga, desde su creación en el año 2001, de evaluar la calidad, seguridad y eficacia de medicamentos prioritarios esenciales para su suministro por las agencias de abastecimiento de la Organización de Naciones Unidas (ONU). Esto es particularmente importante puesto que, por lo general, estos medicamentos no han sido evaluados previamente por autoridades de reglamentación rigurosas (SRAs). El PQTm asegura que la calidad de estos medicamentos es verificada por un organismo independiente para evitar el gasto de recursos en medicamentos de calidad, seguridad y eficacia desconocidas. El programa cubre áreas terapéuticas de crucial importancia como SIDA, malaria, tuberculosis, salud reproductiva, gripe, enfermedades tropicales desatendidas, así como zinc para el tratamiento de la diarrea. Los medicamentos son evaluados en el PQTm por expertos procedentes de autoridades de reglamentación nacional (ARNs) tanto de países desarrollados como de países en desarrollo, de acuerdo con las directrices de la OMS y otras directrices rigurosas internacionalmente aceptadas. La mayor parte de los medicamentos evaluados por el PQTm se fabrican y se venden en países en desarrollo. El PQTm ha precalificado más de 400 medicamentos hasta la fecha, siendo la mayoría de ellos medicamentos genéricos. La lista de medicamentos precalificados se publica en la página web del PQTm y es ampliamente utilizada tanto a nivel nacional como internacional por agencias u organizaciones que abastecen de medicamentos a países donde los sistemas regulatorios son limitados o inexistentes. La precalificación de medicamentos no sustituye, sin embargo, la necesidad de que éstos sean registrados por las ARNs de los países. La OMS no es una autoridad de reglamentación supra-nacional y no puede reemplazar el papel de las ARNs...
An adequate regulation of medicines, such as the one existing in developed countries, ensures that the products that reach the patient have acceptable quality, safety and efficacy, as well as correct product information. These regulatory systems are limited in developing countries, which leads to frequent quality problems with medicines. The World Health Organization (WHO) Prequalification Team-Medicines (PQTm) is responsible, since its inception in 2001, for assessing the quality, safety and efficacy of priority essential medicines for supply by the United Nations (UN) procurement agencies. This is particularly important since most of these medicines have not previously undergone assessment by a stringent regulatory authority (SRA). PQTm guarantees that an independent body verifies the quality of these medicines to ensure that resources are not spent on medicines of unknown quality, safety and efficacy. The programme covers therapeutic areas of critical importance such as HIV, malaria, tuberculosis, reproductive health, influenza, and neglected tropical diseases, as well as zinc for the treatment of diarrhea. In PQTm medicines are assessed, by experts from national regulatory authorities (NRAs) from both developed and developing countries, according to WHO guidelines and other internationally accepted stringent regulatory guidelines. Most of the medicines assessed by PQTm are manufactured and sold in developing countries. More than 400 medicinal products have been prequalified to-date by PQTm, most of them multisource products (generics). The list of prequalified medicines is published in PQTm website and is widely used at national and international level by agencies and organizations that supply medicines in countries where national regulatory systems are weak or non-existent. The prequalification of medicines, however does not obviate the need for registration of these medicines by NRAs in the countries. WHO is not a supra-national regulatory authority and cannot bypass NRAs. Quality assessment of a medicine also requires quality assessment of the active pharmaceutical ingredient(s) (APIs) that are part of the finished product, along with the excipients. This is the approach adopted by all SRAs since a quality medicine starts with a quality API. A quality API is an active substance that presents adequate physicochemical and purity properties and is produced in a consistent manner in a manufacturing site that complies with good manufacturing practice (GMP). Since the late 1980s, there are international stringent regulatory guidelines related to the quality of APIs. These guidelines are aimed at applicants for the purpose of issuing a marketing authorization and require that the applicants present complete data about the manufacture and control of the APIs for a detailed assessment. However, as of today very few NRAs from developing countries perform a complete assessment of the quality of APIs as part of their evaluation to issue marketing authorizations for medicines...
An adequate regulation of medicines, such as the one existing in developed countries, ensures that the products that reach the patient have acceptable quality, safety and efficacy, as well as correct product information. These regulatory systems are limited in developing countries, which leads to frequent quality problems with medicines. The World Health Organization (WHO) Prequalification Team-Medicines (PQTm) is responsible, since its inception in 2001, for assessing the quality, safety and efficacy of priority essential medicines for supply by the United Nations (UN) procurement agencies. This is particularly important since most of these medicines have not previously undergone assessment by a stringent regulatory authority (SRA). PQTm guarantees that an independent body verifies the quality of these medicines to ensure that resources are not spent on medicines of unknown quality, safety and efficacy. The programme covers therapeutic areas of critical importance such as HIV, malaria, tuberculosis, reproductive health, influenza, and neglected tropical diseases, as well as zinc for the treatment of diarrhea. In PQTm medicines are assessed, by experts from national regulatory authorities (NRAs) from both developed and developing countries, according to WHO guidelines and other internationally accepted stringent regulatory guidelines. Most of the medicines assessed by PQTm are manufactured and sold in developing countries. More than 400 medicinal products have been prequalified to-date by PQTm, most of them multisource products (generics). The list of prequalified medicines is published in PQTm website and is widely used at national and international level by agencies and organizations that supply medicines in countries where national regulatory systems are weak or non-existent. The prequalification of medicines, however does not obviate the need for registration of these medicines by NRAs in the countries. WHO is not a supra-national regulatory authority and cannot bypass NRAs. Quality assessment of a medicine also requires quality assessment of the active pharmaceutical ingredient(s) (APIs) that are part of the finished product, along with the excipients. This is the approach adopted by all SRAs since a quality medicine starts with a quality API. A quality API is an active substance that presents adequate physicochemical and purity properties and is produced in a consistent manner in a manufacturing site that complies with good manufacturing practice (GMP). Since the late 1980s, there are international stringent regulatory guidelines related to the quality of APIs. These guidelines are aimed at applicants for the purpose of issuing a marketing authorization and require that the applicants present complete data about the manufacture and control of the APIs for a detailed assessment. However, as of today very few NRAs from developing countries perform a complete assessment of the quality of APIs as part of their evaluation to issue marketing authorizations for medicines...
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Tesis inédita de la Universidad Complutense de Madrid, Facultad de Farmacia, Departamento de Farmacia y Tecnología Farmacéutica, leída el 05/07/2016