The US FDA has released new Guidance for Industry: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic, available at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM080534.pdf
[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Health Surveillance Agency (Anvisa) grants the endorsement for the commercialization of four (4) generic medicines unpublished in Brazil.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Completing the list of the four unpublished generic drugs approved by Anvisa is Testosterone Undecilate.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
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.
Go to Q7 using this link: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM605076.pdf
[Original Text in English]
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.
For more information go to: http://www.digemid.minsa.gob.pe/main.asp?Seccion=3&IdItem=2127
[Original Text in Spanish]
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.
More information by the link: http://www.medicamentos.gob.sv/index.php/es/secciones-m/noticias-dnm/257-convenio-interinstitucional
[Original text in Spanish]
The Secretary of Health, José Narro Robles, spearheaded the launching of the Sixteenth Package of Generic Drugs, within which four active substances were released, allowing 50 quality, safe and low-cost medicines to enter the market.
Accompanied by the head of the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), Julio Sánchez and Tépoz, and the presidents of the National Association of Manufacturers of Medicines and the National Chamber of the Pharmaceutical Industry, Dagoberto Cortés Cervantes and Guillermo Funes Rodríguez, respectively, Narro Robles stressed that the generic market has allowed savings of 26 thousand 102 million pesos.
He specified that with the Strategy for the Release of Generic Drugs for the Saving of Families, quality drugs are offered at low cost, to address the main diseases that afflict the population.
For more information go to
Más informaciones por el enlace: https://www.gob.mx/cofepris/articulos/se-libera-el-decimo-sexto-paquete-de-medicamentos-genericos-154813?idiom=es
[Original in Spanish]
ANMAT approves, through Provision No. 3602/2018, a new “Guide to Good Manufacturing Practices for Producers, Importers / Exporters of Medicinal Products for Human Use”
More information by the link: http://www.anmat.gov.ar/boletin_anmat/BO/Disposicion_3602-2018.pdf
[Original in Spanish]
Created, through Ministerial Ordinance No. 292, within the National Pharmacovigilance System, the additional surveillance modality as an intermediate category between passive (spontaneous report) and active (intensive) pharmacovigilance, foreseen in Ordinance No. 798 of 12 December 2014.
The medicines to which the additional surveillance modality is applied will be defined by the Department of Medicines, which may include those containing a new active ingredient, biotechnological medicines and the medicines to which data related to the post authorization are required.
This condition will be provided when granting the registration of a product or its renewal. It may also be determined later, in the event that warnings arise that warrant it, after having seen the marketing authorization holders.
For more information go to: http://www.msp.gub.uy/sites/default/files/archivos_adjuntos/ord_292_2018%20%203709.pdf
More information by the link
El producto Ventolin Inhalador 100 mcg fue investigado, constatándose que no corresponden a unidades legítimamente fabricadas por GSK, presentando diferencias en la coloración de los textos, diferencia en el código de barra, diferencia en el dispositivo, diferencia en el inserto, diferencia en la marca de agua en el etiquetado de seguridad y en el frasco inhalador, fecha de vencimiento la cual no corresponde al tiempo de vida del producto con número de lote A22M.
Más informaciones por los enlaces
Más informaciones por el enlace https://www.gob.mx/cofepris/articulos/la-cofepris-alerta-sobre-el-producto-tradol-tramadol-de-100mg-2ml?idiom=es
