Xiaoming Xu, Ph.D., Senior Staff Fellow, Office of Testing and Research, Office of Pharmaceutical Quality, CDER
The use of nanotechnology in products regulated by the FDA has been ongoing for several decades and has included foods, cosmetics, medical devices and drugs. Within the purview of FDA’s Center for Drug Evaluation and Research (CDER), there is great diversity in drug products containing nanomaterials.
There has been a steady increase in the number of approved drug products containing nanomaterials, including investigational new drugs, new drug applications, and abbreviated new drug applications (commonly known as generics). More than 60 applications have been approved since the early 1970s, and interest continues to rise.
Drug products containing nanomaterials are unique in several ways because they may take on different chemical, physical, or biological properties compared to other types of drugs. In some instances, this may impact the quality, safety, or efficacy of the product. For example, drug products containing nanomaterials may follow a different pathway in the body compared to a small molecule drug. After a drug product formulated as a nanomaterial enters the bloodstream, it could interact with specialized immune cells called macrophages, which engulf and transport a drug to the location for which it has been programmed, such as where bacteria, fungi, or viruses reside. These areas are typically difficult to reach for a small molecule.
In another example, a drug formulated as a nanomaterial may have a special “coating” that prevents it from interacting with immune cells so that the drug can circulate in the bloodstream for prolonged periods of time until it reaches tumor tissues. The ability to target areas of the body and bypass others can significantly reduce the risk of side effects, such as toxicity to nontarget organs, and potentially increase the effectiveness of the treatment. For these reasons, nanomaterials are most frequently used in the treatment of cancer or infections. Formulations like liposomes, nanocrystals and nano-emulsions are among the most common types of drug products containing nanomaterials being approved.
Consultores de la Organización Panamericana de la Salud-OPS/OMS, en compañía de referentes del Programa Nacional de Control de la Tuberculosis del Ministerio de Salud, realizaron una visita de monitoreo para la verificación del “Manejo Clínico y Programático de Tuberculosis Drogorresistente”, en la Red de Barrio Obrero.
En este sentido, se hicieron presentes en la sede del Hospital General Barrio Obrero donde fueron recibidos por autoridades y responsables del Programa de TB, para luego trasladarse hasta otros establecimientos componentes de la Red de Barrio Obrero. Como los servicios de San Alfonso, Centro de Salud N° 8 y la Unidad de la penitenciaría de Tacumbú.
Durante el recorrido verificaron expedientes clínicos de pacientes afectados por Tuberculosis Drogorresistente, y monitorearon la organización de los laboratorios que procesan las muestras para el diagnóstico de TB, como también los avances en la implementación de fármaco-vigilancia activa, para supervisar y evaluar la respuesta de los tratamientos.
Los resultados del monitoreo serán presentados al Ministro de Salud, confirmaron los visitantes.
La Directora Nacional de Medicamentos, Dra. Leonor Morales de Acosta participó en la reunión de la Red Centroamericana de Autoridades Reguladoras de Medicamentos y Otras Tecnologías.
La reunión se desarrolló en República Dominicana, los días 23 y 24 de abril. En dicho encuentro participaron las Autoridades Regulatorias de Centroamérica y República Dominicana y se abordaron temas como la Integración Regional de la Salud y la Validación de la Estrategia de Medicamentos para Centroamérica y República Dominicana.
Además, se discutieron las brechas regulatorias en los países de la región y se hicieron los planteamientos de las líneas de trabajo integrado, estas líneas de trabajo no solo fortalecerán las acciones regulatorias de las autoridades participantes, sino que también la creación de una propuesta de herramienta regional para combatir la falsificación de medicamentos.
Importante contar con un marco de referencia voluntario para avanzar en las decisiones regulatorias del grupo: Julio Sánchez y Tépoz, titular de COFEPRIS
ANMAT: Publicación de la Revista Ciencia Reguladora Nº 2
ANMAT presenta el segundo número de “Ciencia Reguladora”, la revista que comunica aquellos trabajos científicos y de divulgación desarrollados por todas las áreas del organismo.
A continuación están los contenidos de la publicación:
Desarrollo y validación de una metodología de cuantificación de fluconazol por UHPLC para emplear en el ensayo de disolución de comprimidos
Ciclofosfamida inyectable: Primera investigación del Programa de Vigilancia Farmacéutica Activa
Verificación intralaboratorio de la norma iso 6579: Método horizontal para la detección de salmonella spp. en fórmula en polvo para lactantes
Revisión Bibliográfica Vacuna de Hepatitis B: Productos registrados en Argentina y métodos generales de valoración de potencia
Enfoque Regulatorio Dispositivos de tabaco sin combustión
La aplicación de la nanotecnología en medicamentos: Oportunidades y desafíos
El observatorio ANMAT y la Ciencia Reguladora: Saber dónde se quiere ir…
Estado de Situación La Comisión de Productos para la Salud. Marco, misión y estado de la convergencia regulatoria de los estados parte del Mercosur
With the commitment to redouble efforts to ensure that Peruvians have access to quality, safe and effective medicines, the pharmacist Enma Violeta Córdova Espinoza, assumed the position of Director General of the Directorate General of Medicines, Supplies and Drugs (Digemid) of the Ministry of Health (Minsa).
During his presentation to the workers of the institution, Córdova said that his management will be characterized by promoting a joint and comprehensive work with the servers of Digemid, in order to strengthen its regulatory role and contribute to the health care of Peruvians.
His management will be characterized by dialogue and open doors, he announced that efforts will be redoubled in order to achieve recognition as “National Regulatory Authority of Regional Reference for medicines and biological products Level IV”, the highest rating awarded the Pan American Health Organization (PAHO / WHO).
The former director general of the Digemid Susana Vásquez, thanked the support of the institution’s servants during her administration and highlighted the commitment they demonstrate to the health of our population.
Santo Domingo. In the meeting, RedCAM will address key points referred to the “Regional Strategy” for access, quality and regulatory mechanisms to ensure the rational use of medicines by the countries of the region.
The meeting is held as part of the activities of the Regulatory Week and within the framework of the Presidency Pro-Tempore of COMISCA, which holds the Dominican Republic until June 2018.
The Minister of Health, Altagracia Guzmán Marcelino and Dr. María De los Ángeles Campos, on behalf of the Executive Secretariat of COMISCA, Dr. Alejandro Solís Martínez, opened the meeting.
Both agreed on the challenges faced by the Regulatory Authorities of Medicines of Central America and the Dominican Republic RedCAM, such as the strengthening of the role of stewardship and regulation, an essential element for compliance with public health.
Between April 26 and 27, the Regulatory Authorities of Medicines of Argentina (ANMAT), Brazil (ANVISA), Canada (Health Canada), Chile (ISP), Colombia (INVIMA), Cuba (CECMED), United States (USFDA) and Mexico (COFEPRIS) meet in the city of Santiago, Chile. To date, these are the authorities considered level IV in the Americas region.
On this occasion, a review will be made of the state of progress of the priority projects committed in the last NRAr meeting held in December 2017, in Washington DC, United States. In addition, the work agenda includes the review of the NRAr cooperation activities with other authorities in the region that does not have the same level of development, the review of the progress in the implementation of the Global Tool of the World Health Organization (WHO), and the presentation of topics of interest or concern to the NRAs, in order to identify future actions, in addition to preparing the Work Plan for the years 2018-2019.
More information about the Annual Meeting in Chile available through the link http://www.ispch.cl/arns
System for Evaluation of the National Regulatory Authorities for Medicines
The Designation of Regional Reference Authority (NRAr) corresponds to the Regulatory Authorities that reach level IV of a rating system through evaluation based on indicators contained in the data collection tool, which is based on recommendations of the World Health Organization for the strengthening of Regulatory Bodies.
A level IV NRAr represents that the authority is competent and efficient in carrying out the regulatory functions recommended by PAHO / WHO to guarantee the efficacy, safety and quality of medicines.
One of its objectives is to support the Pan American Health Organization in strengthening activities of other national regulatory authorities in the Region.
More information about the System for Evaluation of the National Regulatory Authorities for Medicines is available here.
FDA released the Center For Drug Evaluation and Research (CDER) Drug Safety Priorities 2017 annual report. The report describes CDER’s work in 2017 to enhance drug safety for the American public, including safety surveillance and oversight of marketed drug products, the importance of real-world evidence to help advance drug safety science, new tools and approaches for fighting the opioid crisis, safety oversight for generic drugs, efforts to reduce preventable harm from medications, compounded drugs – continuing regulatory and oversight efforts, and diverse strategies, tools and services for communicating drug safety. REPORT
The report describes many ways CDER worked in 2017 to enhance drug safety for the American public. These include:
Safety surveillance and oversight of marketed drug products
The importance of real-world evidence to help advance drug safety science:
New tools and new approaches for fighting our Nation’s opioid crisis
Safety oversight for generic drugs
Efforts to reduce preventable harm from medications
Compounded drugs – continuing regulatory and oversight efforts
Diverse strategies, tools, and services for communicating drug safety
