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Canada: Regulation of non-prescription drugs

Find out how non-prescription drugs are regulated and licensed.

Non-prescription drugs, also called over-the-counter drugs, are health products that can be bought without a doctor’s prescription.

Canada regulates non-prescription drugs to:

  • make sure they’re safe to use
  • reduce health risks to Canadians

For more information go to https://www.canada.ca/en/health-canada/services/self-care-regulation-non-prescription-drugs.html#s1

 
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Ecuador: Arcsa controls laboratories of natural products in Ambato

Technicians of the Zonal Coordination 3 of the National Agency of Regulation, Control and Sanitary Vigilance (Arcsa) visited laboratories of natural products of Ambato, with the aim of verifying the hygienic-sanitary conditions, storage and production processes used for the elaboration of this type of products that are distributed nationwide.
“This type of inspection is carried out permanently throughout the area in order to provide recommendations for improvement in the development of natural products and food supplements, to protect the health of the population that consumes them,” said Carlos Barreno, technician of the Coordination Zonal 3 of Arcsa.
As part of the control, it was verified that the products comply with the approved labeling in the Sanitary Registry, as well as with the current sanitary regulations, to avoid possible cases of misleading advertising and confusion in the nutritional and therapeutic properties of said products.

For more information go to https://www.controlsanitario.gob.ec/arcsa-controla-laboratorios-de-productos-naturales-en-ambato/

 
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Mexico: Second Symposium of medicinal cannabis for health professionals

The Commissioner for Protection against Sanitary Risks, Julio Sánchez and Tépoz, inaugurated today the “Second Symposium of medicinal cannabis for health professionals”, organized by the Director of CannabiSalud, Lorena Beltrán.

Source: https://www.gob.mx/cofepris/articulos/segundo-simposio-de-cannabis-medicinal-para-profesionales-de-la-salud?idiom=es

 
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Have you ever donated blood? Give Blood often. Blood donation matters for people’s health, especially voluntary donation. Share Life.

World Blood Donor Day 2018

Be there for someone else. Give blood. Share life. 14 June 2018 Every year, on 14 June, countries around the world celebrate World Blood Donor Day. The event serves to thank voluntary, unpaid blood donors for their life-saving gifts of blood and to raise awareness of the need for regular blood donations to ensure the quality, safety and availability of blood and blood products for patients in need.

For more information go to https://www.paho.org/hq/index.php?option=com_content&view=article&id=14307%3Aworld-blood-donor-day-2018&catid=8699%3Awbdd&Itemid=72270&lang=en

 
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Mexico: COFEPRIS and the National Federation of Traditional and Herbal Medicine sign a collaboration agreement

[Original Text in Spanish]

The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and the National Federation of the Herbalist Industry, Traditional and Naturist Alternative Medicine A.C. (FNIHMATN), today signed a collaboration agreement whose main objective is to establish the necessary actions to have sanitary regulations that regulate the products and plants used by this sector as well as to improve and update the technical processes and continuous training.

For more information go to https://www.gob.mx/cofepris/articulos/la-cofepris-y-la-federacion-nacional-de-medicina-tradicional-y-herbolaria-firman-convenio-de-colaboracion-160164?idiom=es 

 
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Uruguay: Medication error between packages in vials of similar appearance of transamine and bupicacaine

[Original Text in Spanish]

Considering new sentinel events linked to the use of different drugs packaged in vials of similar appearance, the Ministry of Public Health warns health institutions to take precautions in the purchase of high-risk medications.

(…)

For More information go to http://www.msp.gub.uy/sites/default/files/archivos_adjuntos/comunicado%20digesa.pdf

 
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WEBINAR – FDA Drug Topics: FDA’s Web Resources Available to Health Care Providers Who Prescribe and Dispense Medications with Risk Evaluation and Mitigation Strategies (REMS) – June 26, 2018

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians. Interact with FDA staff from a variety of divisions and learn more about the FDA and drug regulation!

On Tuesday, June 26, 2018, at 1:00PM (EDT), CDER’s Office of Communication, Division of Drug Information (DDI) will host a webinar titled: FDA Drug Topics: FDA’s Web Resources Available to Health Care Providers Who Prescribe and Dispense Medications with Risk Evaluation and Mitigation Strategies (REMS). This webinar will introduce health care professionals to web resources about Risk Evaluation and Mitigation Strategies (REMS), including a REMS resource portal and the REMS@FDA website, and will focus on what type of information is available, where, and how to navigate these resources.

For more information go to https://www.fda.gov/AboutFDA/WorkingatFDA/FellowshipInternshipGraduateFacultyPrograms/PharmacyStudentExperientialProgramCDER/ucm607741.htm

 
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Dominican Republic: MS unanimously approves CBME 2018, includes 797 drugs

[Original Text in Spanish]

Santo Domingo.-A total of 797 drugs are contained in the seventh edition of the Basic Table of Essential Medicines (CBME) 2018, presented by the Ministry of Health with the purpose of expanding the population’s access to pharmaceutical products with proven safety and efficacy therapeutic, at reasonable costs.

The Minister of Health, Dr. Rafael Sánchez Cárdenas, said that the institution continues the journey of reaching the goals that have been proposed, in the sense of guaranteeing to the citizenship, safe, quality and affordable medicines, mainly to the sectors with the least resources. economic

For this year 2018, the approval of the Basic Table of Drugs was approved by all interested sectors and 28 new active ingredients were added corresponding to psychotropic drugs, tuberculosis and HIV treatments, cardiovascular, analgesics, antibiotics, antiepileptic drugs, contraceptives, medicines for hepatitis B and C.

This Basic Chart constitutes a tool for the acquisition, supply, financing and prescription of medicines. It covers medicines for the treatment of 85% of the main diseases that correspond to the epidemiological profile and morbidity of the Dominican family.

For more information go to http://msp.gob.do/MS-aprueba-nuevo-Cuadro-Basico-de-Medicamentos-Esenciales-CBME-2018-incluye-mas-de-700-farmacos

 

 
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Mexico: Challenge of the health authorities, to avoid the commercialization of falsified and low quality medical products: JSyT

[Original Text in Spanish}

He also presented the National Strategy of Action on Resistance to Antimicrobials

The Federal Commissioner for Protection against Health Risks, Julio Sanchez and Tépoz, warned that the challenge of the health authorities in the world is to prevent and prevent in their countries are marketed low quality or counterfeit medical products, as they do not guarantee quality , safety and efficacy.

By participating in the panel “The critical role of regulation in combating low-quality and counterfeit medical products”, in the framework of the 71st World Health Assembly, in Geneva, Switzerland, held that “quality medical products Substandard and counterfeit are a risk to the health of the population and it is up to us, as regulatory authorities, to avoid commercialization in our countries at all costs. ”
“The National Drug Regulatory Authorities require increasingly diverse and complex regulatory competencies to comply with the safety and quality of regulated medical products and thereby prevent the entry into the market of counterfeit medical products of low quality in the market. The challenges are significant and could lead to various economic and public health risks that would negatively impact on mortality, morbidity, quality of life, patient and consumer productivity, as well as on the general economic well-being of the countries, “said the owner. the COFEPRIS.

Before representatives of the World Health Organization (WHO) and health authorities of various countries, stressed that the safety and quality of medical products and greater access to them, the transparency and accuracy of information in regulatory acts, as well as the adoption of timely methodologies based on evidence to remove suspicious products from the market and thus prevent damage and mitigate risks to public health, are essential to efficiently regulate potential health risks.
In another meeting, Julio Sánchez and Tépoz, with the representation of the Government of Mexico, presented the National Strategy of Action on Resistance to Antimicrobials.

The Federal Commissioner explained that the 71st World Health Assembly addressed issues of public health, environment and climate change; global shortage of medicines and vaccines and their access; global strategy and public health action plan; innovation and intellectual property; global governance to guarantee sustainable global actions; nutrition of the mother, the infant and the young child; as well as the dimension of public health in the world drug problem.

Source: https://www.gob.mx/cofepris/articulos/reto-de-las-autoridades-sanitarias-evitar-que-se-comercialicen-productos-medicos-falsos-y-de-baja-calidad-jsyt-158040?idiom=es

 
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Cuba: Guide for the Realization of Pharmacogenomic Studies, First in the Region

Resolution 75/2018 of the Center for the State Control of the Quality of Medicines and Medical Devices (CECMED) approves and enforces the Guide for the performance of pharmacogenomic studies during the development of medicines. According to CECMED, this guide is considered the first regulatory provision on the subject in the region. This provision sets the guidelines for conducting pharmacogenomic evaluations during the development of medicines of the national pharmaceutical industry.

The guide includes regulatory requirements for pharmacogenomic evaluation: the reception, coding and storage of samples, the use of biomarkers and the ethics of research. Pharmacogenomics allows therapeutic decisions to be guided by the molecular attributes of each patient, allows identifying patients who will respond to treatment, which implies an increase in therapeutic activity of incalculable scope, also has great impact in terms of safety, since the patients who will not respond, when not receiving the treatment, will be saved toxicities that would limit their quality of life, finally the impact on the efficiency, means a reduction of the direct costs of the medicines.

Source: CECMED, Dr. Diadelis Remirez (http://www.cecmed.cu/content/guia-para-la-realizacion-de-estudios-farmacogenomicos-primera-en-la-region)