[Original text in Spanish]

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

Acceso a la revista por medio del enlace: http://www.anmat.gov.ar/comunicados/Ciencia_Reguladora_N2-Abril_2018.pdf

[Original text in Spanish]

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.

Source: http://www.digemid.minsa.gob.pe/main.asp?Seccion=3&IdItem=2128

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.

The meeting may be accompanied by the link http://www.ispch.cl/reunionarn

Activity program

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

Source: FDA Voice.

[Original text in Portuguese]

The Brazilian Health Surveillance Agency (Anvisa) grants the endorsement for the commercialization of four (4) generic medicines unpublished in Brazil. One of them is Entricitabine combined with Tenofovir Fumarate Desoproxil, a product that will be part of the therapeutic arsenal used to treat people living with HIV. The reference product is Truvada, which includes pre-exposure prophylaxis (PReP) used to reduce the risk of sexually acquired infection in high-risk adults. In Brazil, the holder of the registration is Blanver Farmoquímica e Farmacêutica S / A.

Another new generic product with registration approved by Anvisa is Perindopril Erbumine combined with Indapamide, indicated for the treatment of arterial hypertension, also known as high blood pressure. According to the Brazilian Society of Hypertension (SBH), this disease is very common, affecting one in four adults. In this case, the company holding the registration in the country is EMS S / A.

Among the products approved by Anvisa is also the unprecedented generic Bilastine, indicated for the symptomatic treatment of allergic rhinoconjunctivitis (intermittent or persistent) and urticaria. The company that holds the registration is EMS S / A.

Completing the list of the four unpublished generic drugs approved by Anvisa is Testosterone Undecilate. This product will be used in sex hormone replacement therapies in men with primary and secondary hypogonadism. The holder of the registration of this medicine in Brazil is Eurofarma Laboratório S / A.

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For more information go to http://portal.anvisa.gov.br/rss/-/asset_publisher/Zk4q6UQCj9Pn/content/id/4337807