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
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.
FDA announced the availability of a final guidance for industry entitled ‘‘Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients: Questions and Answers.’’ This guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation, and is intended to clarify uncertainties due to the interpretation of certain sections of ICH Q7 and to help ensure that all active pharmaceutical ingredients (APIs) meet the standards for quality and purity they purport or are represented to possess.
The General Directorate of Medicines, Supplies and Drugs (Digemid) of the Ministry of Health (MINSA) has been optimizing its internal processes to achieve recognition as “National Regulatory Authority of Regional Reference for medicines and biological products Level IV”, the highest rating grants the Pan American Health Organization (PAHO / WHO) to ensure the efficacy, safety and quality of medicines.
This certification will facilitate the exchange of public information within the framework of current national legislations, the establishment of mutually agreed mechanisms that favor the processes of mutual recognition among regulatory authorities and participate in the processes of quality assurance and effectiveness of products purchased by PAHO on behalf of the countries.
In addition, it will support the strengthening activities of other national regulatory authorities in the region as well as implement the “Inter-institutional Cooperation Agreement of the Health Authorities of the Pacific Alliance Countries,” in the sanitary registration and certification processes. manufacturing practices.
Dr. Reina Leonor Morales de Acosta, National Director of Drugs and Lic. Juan Ernesto Machón, President of the College of Chemists and Pharmacists of El Salvador, signed this day an Inter-institutional Cooperation Agreement in order to achieve and maintain a better execution of its responsibilities, especially those related to the scientific and academic field applied to pharmaceutical regulation.
The agreement also includes cooperation in aspects related to the promotion of pharmaceutical regulation and its regulation, and in particular to the promotion of the rational use of medicines.
In this instrument, it is agreed to establish a mechanism of technical and logistic cooperation among the signatory institutions, in order to achieve the proposed objectives, which include the training and execution of scientific and academic activities. To this end, a work plan will be drawn up jointly between the parties.
Both institutions will coordinate the execution of the necessary events and activities that provide scientific and academic results. These results should be aimed at strengthening and strengthening the regulatory and educational capacities in the pharmaceutical-health field.
In addition, the signatory institutions will be responsible for the dissemination of the results resulting from said scientific and academic activities related to the object of this agreement.
